Engineering Compliance Manager – London

Reena Dhana at CK Science is currently recruiting for an Engineering Compliance Manager to join a Global Pharmaceutical Organisation at their site in London, on a full time, 6 month contract.

Responsibilities:

As an Engineering Compliance Manager the main purpose of your role will be:

  • To ensure that all Manufacturing Sites are supported with documented technical standards
  • To ensure that the necessary systems, processes, procedures and training is in place so that line managers in Manufacturing Engineering can ensure their staff remain compliant with the cGMP and Engineering standards.

Qualifications and skills:

As an Engineering Compliance Manager you will have the following qualifications, skills and experience:

  • Previous experience in an operational or managerial engineering role would be ideal.
  • You will have technical expert in all areas of Engineering ideally in the Pharmaceutical industry.

As an Engineering Compliance Manager, you will be joining a Global Pharmaceutical Organisation who in return are offering a competitive salary

Reena Dhana - Recruiter at CK ScienceHow to apply:

For more information or to apply for the role of Engineering Compliance Manager please contact Reena Dhana on 01438 723 500 or email rdhana@ckscience.co.uk. Please quote reference ST24933 in all correspondence.

 

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Compliance Process Engineer – Oxfordshire

Jason Johal at CK Science is currently recruiting for a Compliance Process Engineer  to join a global, broad-based health care company at their site in Oxfordshire.

The Role:

This aim of this Compliance Process Engineer job is to coordinate and direct compliance issues within the Operations Engineering department of a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. They will ensure a consistent approach is taken to resolving quality issues including ERs, CAPAs, Calibration Alerts and Post Investigations.

Responsibilities:

The responsibilities of this Compliance Process Engineer role will include:

  • Providing technical support to the calibration department to ensure that all calibration activities meet divisional and corporate requirements.
  • Supporting the introduction of new products and / or equipment through effectively managing the engineering document change process.
  • Seeking new ways of improving the efficiency of the Engineering Compliance group. Actively promoting the use of continuous improvement programs.
  • Developing strong links within Operations department to ensure service provided meets business requirements.
  • Understanding regulatory and corporate requirements to ensure the Operations Engineering department continues to meet cGMP and leading teams to deliver compliance projects and quality initiatives.

The successful incumbent will be expected to develop projects from concept through to implementation with the aim of continually improving Engineering processes including preventative and demand maintenance programs. They will also be responsible for authoring, reviewing and updating Operations Engineering documents to ensure compliance with regulatory, site and corporate requirements and for providing SME support to internal and external audits as required.

Qualifications and skills:

The ideal candidate for this Compliance Process Engineer job will have experience within a regulated industry, preferably medical devices or pharmaceutical along with a proven knowledge of engineering and calibration processes. They will also have:

  • The ability to take prompt action to accomplish objectives and to work under their own initiative.
  • A proven track record of technical report authoring and of delivering assigned projects / goals to on time, within budget and ensuring that internal customer requirements are meet.
  • Experience of working within a high volume highly regulated manufacturing environment with full membership of a recognised professional Engineering or Quality body is desirable.

How to apply:

Apply online for this role

For more information or to apply for this Compliance Process Engineer role please contact Jason Johal on 01438 743 047 or email jjohal@ckscience.co.uk. Please quote reference ST23812 in all correspondence.

 

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Environmental Manager Role – North Scotland

Barney Smith is currently recruiting for an Environmental Manager to join a Manufacturer of high quality products based in the North of Scotland.

Responsibilities:

You will be responsible for managing all aspects of Environmental compliance and performance onsite including maintenance of ISO 9001 and 14001, PPC permits, COSHH regulations, IPPC, and waste regulations including control of pollution act and water framework directive, freshwater fish directive and European Emission Trading Scheme.

Qualifications:

You must be qualified to minimum HND/HNC in an environmental or science based subject or possess equivalent experience and have a proven track record in environmental management in chemical or manufacturing industries. 

Apply now:

For more information or to apply for this Environmental Manager position, please contact Barney Smith on 0191 384 8905 or bsmith@ckscience.co.uk.  Please quote reference DH22425 in all correspondence.

                                                           Click here to apply now!

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Associate Director Job (Pharmaceuticals, Quality Auditing) – Suffolk, UK

We are currently looking for an Associate Director to join a global pharmaceutical company in the Suffolk region.

As Associate Director, you will be responsible for developing and managing audit programs for healthcare compliance and privacy at the company’s facilities to ensure they are meeting the relevant company and regulatory standards.

 

As Associate Director, you will also:

  • Develop and introduce a process for carrying out healthcare compliance audits. This will include the auditing procedure and the reporting of audit results and metrics to senior management.
  • Train company auditors in healthcare compliance auditing.
  • Auditing company facilities including country offices and relevant business units for healthcare compliance.
  • Develop and introduce a process for carrying out privacy audits. This will include the auditing procedure and the reporting of audit results and metrics to senior management.  The audits will check that the organization can both meet the requirements of the company and the relevant regulatory requirements.
  • Train auditors in privacy auditing.
  • Auditing facilities for privacy.

 

Person specification:

The ideal candidate for this Associate Director position will have the following qualifications, skills and experience:

  • Possess a Bachelors degree (or equivalent) with related industry experience.
  • Extensive experience in auditing
  • Expert knowledge of healthcare compliance and/or privacy requirements for the pharmaceutical and/or medical device industries
  • Strong written and oral communication skills.

 

How to apply

For more information or to apply for this Associate Director position, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST22200 in all correspondence.

 

Click here to apply online!

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Regulatory Affairs Manager Job – North Scotland

Our client, a Scottish diagnostics company require a Regulatory Affairs Manager on a temporary basis to cover maternity leave.

Reporting to the Quality Assurance/Regulatory Affairs Director you will be responsible for a small team ensuring company activities are in compliance with regulations applicable to the diagnostics industry.

To be considered for this Regulatory Affairs Manager position, you must have the following skills and experience:

  • Have experience of working within or in close interaction with the RA team in relation to regulatory submissions or verification activities.
  • Be knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA.
  • Have experience in interacting with external partners and regulatory agencies including the FDA.
  • Have the ability to build key relationships within the senior management team to promote and direct RA within the organisation.
  • Have supervisory experience.
  • Educated to degree level in a life science subject or have demonstrable experience in a regulatory affairs position.

 

How to apply

For more information or to apply for this Regulatory Affairs Manager position, please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk.

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Process Compliance Officer Job (Chemicals) – East Midlands, UK

Our client is a leading supplier of closed-die forgings to the automotive, aerospace and power generation industries. Production includes aero-engine rotating parts in titanium and nickel-base super alloys, and steel and alloy parts for power transmission and bearing applications.

The company are currently looking for a Process Compliance Officer to join the Certification team responsible for stamping and certifying all production that leaves the facility.

Responsibilities:

This Process Compliance Officer role will involve:

Reviewing documentation in line with company and departmental procedures to ensure full compliance to drawing, specification and customer specific requirements. The role will involve creating certificates of conformities to enable final releaseof product for shipment.

Person Specification:

The ideal candidate will come for a production environment and have experience in dealing with documents and specifications to a high degree of accuracy. Ideally you will have worked in a compliance or quality role where attention to detail is paramount. You will have a strong eye for detail and precision, have good IT skills (Excel, Word) and be able wok on their own initiative. The role will involve working to strict deadlines and will result in busy ends to the week/month resulting in initial work at the weekends.

Apply Now

For more information or to apply for this Process Compliance Officer position, please contact Russell Oakley at CK Science on 0114 283 9956 or email roakley@ckscience.co.uk. Please quote reference SH21336 in all correspondence.

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Technical Compliance Assistant Job – North East, UK

Our client is a food manufacturer based in the North East of England. They require a Technical Compliance Assistant  to join their technical compliance team.

 

Responsibilities:

Reporting to the Compliance Manager, as Technical Compliance Assistant, your main responsibilities will include:

  • To ensure all manufactured products comply with regulatory, company and customer standards
  • To ensure relevant technical and regulatory information is sourced, collated and made available to relevant teams
  • To validate legal label information for all new products and approve packaging and artwork.

 

Person Specification:

You must be qualified to HNC/HND in a related subject or possess equivalent industrial experience. You must also have a proven track record in food labelling and packaging information.

 

Apply Now

For more information, or to apply for this Technical Compliance Assistant position, please contact Barney Smith at CK Science on 0191 384 8905 or email bsmith@ckscience.co.uk. Entitlement to work in the EEA is essential. Please quote reference DH21175 in all correspondence.

 

Alternatively, click here to apply for this Technical Compliance Assistant position online now.

 

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Validation Support Technologist Job – West Sussex

My client is looking for a Validation Support Technician to join their Validation team which aims to drive increased Quality, Compliance and Business improvements, by writing and executing validation documents according to a Validation Master Plan. Validation requirements encompass that of newly installed equipment, cleaning, utilities, computer systems and process improvements.

As a Validation Support Technologist  will be responsible for maintaining the existing validation status via review and revalidation and be part of a team that delivers the Validation Master Plan. You will support Process Support and Business Improvement Teams associated with other projects. You will be responsible for all areas of validation within at least one of the four Orals Value Stream production areas.

Ideally you will possess a degree (or equivalent) in a scientific or engineering discipline. It is essential you have experience of previous validation work, ideally within the pharmaceutical sector. You will be able to plan, organise and control workloads of self and others to meet deadlines and deliver schedule and targets. This position is for a minimum of 6 months.

 

Apply Now

For more information or to apply for this Validation Support Technologist position, please contact Julie Marshall at CK Science on 01438 723 500 or email jmarshall@ckscience.co.uk. Please quote reference ST21133 in all correspondence.

 

Alternatively, click here to apply for this Validation Support Technologist position online now.

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Validation Support Technologist (Temporary) – East Sussex, UK

Our client is looking for a Validation Support Technologist to join their Validation team which aims to drive increased Quality, Compliance and Business improvements, by writing and executing validation documents according to a Validation Master Plan.

Validation requirements encompass that of newly installed equipment, cleaning, utilities, computer systems and process improvements. You will be responsible for maintaining the exisiting validation status via review and revalidation and be part of a team that delivers the Valiation Master Plan. You will support Process Support and Business Improvement Teams associated with other projects. You will be responsible for all areas of validation within at least one of the four Orals Value Stream production areas.

The ideal candidate for this Validation Support Technologist position will possess a degree (or equivalent) in a scientific or engineering discipline. It is essential you have experience of previous validation work, ideally within the pharmaceutical sector. You will be able to plan, organise and control workloads of self and others to meet deadlines and deliver schedule and targets. This position is for a minimum of 6 months.

 

Apply Now

For more information, or to apply for this Validation Support Technologist position, please contact Julie Marshall at CK Science on 01438 723 500 or email jmarshall@ckscience.co.uk.Please quote reference ST21010 in all correspondence.

 

Alternatively, click here to apply for this Validation Support Technologist position online now.

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Head of Quality & Compliance Job (CMC Services) – Cambridge, UK

As the Head of Quality and Compliance you will ensure the departments in the division are operating in accordance with appropriate GMP standards and review procedures to identify and implement changes to achieve continuous improvement in quality and compliance. This role is based in Cambridge, UK.

 

Responsibilities:

By working with Heads of Departments you will review operational procedures, SOPs and training in each department and identify and implement changes to improve quality and compliance. You will evaluate whether departmental errors have the potential to occur across the Division or Company and ensure they are investigated thoroughly and appropriate actions put in place to prevent a reoccurrence. You will also ensure that all GMP services provided by the Division meet current and future world-wide regulatory compliance and internationally recognised quality standards.

Key responsibilities of this Head of Quality & Compliance will include reviewing department and divisional quality metrics on a monthly basis and identifying trends and potential issues, reviewing departmental QC procedures and evaluating their effectiveness and robustness, training staff in GMP regulations and quality standards and Identify regulatory and quality training needs. You will also review all CAPA investigations and act as a source of advice for regulatory/quality queries from any member of staff within the Division.

The key aim of this role is to build, lead and motivate an effective quality and compliance team and to co-ordinate and respond to quality queries for both internal and external clients.

 

Person Specification:

The ideal candidate will have a thorough working knowledge of GMP, good communication skills and will be trained in LEAN or Six Sigma. Significant experience of quality management systems is essential as is experience in CMC and commercial drug manufacture.

 

Apply Now

For more information, or to apply for this Head of Quality and Compliance position, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST20961 in all correspondence.

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Quality Assurance Officer Jobs, Pharmaceutical

Our client, a major pharmaceutical company located in County Durham, has a number of long term temporary vacancies for Quality Assurance Officers with relevant experience in product release and cGMP compliance. Some but not all of the positions may involve shift working, for which there is a generous shift allowance.


As a Quality Assurance Officer, you will ensure that all products released for sale or further processing comply with cGMPstandards, product quality specifications and regulatory requirements. You will also generate and review product related technical documents, and collate and interpret data such as analytical results/trends and regulatory, validation and engineeringinformation. Working as a  Quality Assurance Officer you will also lead and direct investigative work into products failing to meet requisite standards (and regulatory issues). You will also lead investigative work and develop and agree corrective actions.
Our client is looking for individuals with a strong background in Quality Assurance, good knowledge of cGMP and regulatory requirements and the ability to manage multiple activities concurrently within high volume, complex areas. Excellent communications skills are also required, togetherwith demonstrable leadership and decision-making abilities.

Apply Now

For more information, or to apply for this Quality Assurance Officer position, please contact Graeme on 0191 384 8905 or email gpallas@ckscience.co.uk.

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Quality Assurance Officers (Pharmaceutical Product Release) – County Durham, UK

Our client, a major pharmaceutical company located in County Durham, has a number of long term temporary vacancies for Quality Assurance Officers with relevant experience in product release and cGMP compliance.  Some but not all of these Quality Assurance Officer positions may involve shift working, for which there is a generous shift allowance.

As a Quality Assurance Officer you will have the following responsibilities:

  • You will ensure that all products released for sale or further processing comply with cGMP standards, product quality specifications and regulatory requirements.
  • You will also generate and review product related technical documents, and collate and interpret data such as analytical results/trends and regulatory, validation and engineering information.
  • To lead and direct investigative work into products failing to meet requisite standards (and regulatory issues).
  • You will also lead investigative work and develop and agree corrective actions.

Our client is looking for individuals with a strong background in Quality Assurance, good knowledge of cGMP and regulatory requirements and the ability to manage multiple activities concurrently within high volume, complex areas.  Excellent communications skills are also required, together with demonstrable leadership and decision-making abilities.

 

Apply now

For more information, or to apply for these Quality Assurance Officer roles, please contact Graeme at CK Science on 0191 384 8905 or email gpallas@ckscience.co.uk. Please quote reference DH20139 in all correspondence.

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