Quality Manager – County Durham

Heather Deagle at CK Science is recruiting for an experienced Quality Manager or Qualified Person to work in Sterile production for a major pharmaceutical company based in Durham on a temporary basis initially until the end of the year.

Responsibilities:

The mail function of this Quality Manager role is to provide support for the area on managing issues/deviations to free up time for the Batch Release QP to focus on improvements.

As a Quality Manager you will have the following responsibilities:

  • To lead and direct investigative work into products failing to meet requisite standards (and regulatory issues). Also to develop and agree corrective actions arising from such incidents.
  • Lead deviation investigation clinics, coaching where applicable. To lead, prioritize and provide an effective
  • Product Release Service which ensures that all products released for sale or further processing have a quality appropriate to their intended use i.e. comply with Company GMP standards, Product Quality Specifications and Regulatory requirements.
  • Provide GMP advice on an on going basis
  • Support and influence Quality Improvements to reduce rejects, deviations, complaints and increase productivity.

Qualifications and skills:

The successful candidate for this Quality Manager role will have the following qualifications:

  • Qualified Person status
  • Grad (or equivalent) with several years proven post qualification experience in the pharmaceutical or allied industry
  • Experience in handling regulatory affairs
  • Detailed knowledge of current Good Manufacturing Practice requirements within major pharmaceutical markets.

How to apply:

Apply online:

For more information or to apply for this role please contact Heather Deagle on 0191384 8905 or email hdeagle@ckscience.co.uk. Please quote reference DH24906 in all correspondence.

 

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Semi Solid Analytical Development Chemist – Herts

Jason Johal at CK Science is currently recruiting for a Semi Solid Analytical Development Chemist to join a successful pharmaceutical company that that develops a wide variety of medicines and healthcare products from their site in Hertfordshire on a full time, permanent basis.

The Job:

As a Semi Solid Analytical Development Chemist you will be joining an existing team of analysts who form the Analytical Development Group within the R&D department. In return there is an attractive salary, coupled with excellent benefits and career progression opportunities.

Qualifications:

 The successful Semi Solid Analytical Development Chemist will have the following qualifications, skills & experiences:

  • Development experience of semi solid product including creams, gels, lotions etc.
  • The ability to perform analytical method validations and cleaning validations
  • A strong theoretical and practical understanding of HPLC and GC  
  • Experience of TLC and Titrimetric analysis
  • Relevant experience in developing and validating analytical methods for semi solid product (preferably in a pharmaceutical environment)
  • Experience of HPLC and GC analysis
  • A degree (or equivalent) in a chemistry based discipline  Jason Johal - Manager at CK Science

How to apply:

Apply online:

For more information and to apply for this Semi Solid Analytical Development Chemist position, please contact Jason Johal via email jjohal@ckscience.co.uk or call 01438 723 500.  Please quote reference ST24640 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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Chemistry is Being Celebrated Worldwide in 2011

2011 is the International Year of Chemistry, with chemistry being celebrated worldwide.

The slogan, “Chemistry – our life, our future” is driving forward events such as interactive experiments and lectures worldwide. The events are an attempt to increase public appreciation of chemistry, its ability to meet world needs, interest young people and generate excitement about the future of chemistry.

The year coincides with the 100th anniversary of Marie Curie’s Nobel Prize award, as well as the 100th anniversary of the founding of the International Association of Chemical Societies, meaning 2011 is a chance to celebrate the contribution of women to chemistry and indicate the benefits of international cooperation within the sciences.

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Master Scheduler Job (Pharmaceuticals) – North West

Our client is a global manufacturer of pharmaceuticals and is currently looking for a Master Scheduler to be based in the North West, UK.

The overall job purpose includes:

  • To ensure a high level Master Production Schedule (MPS) is developed for assigned product(s) to meet customer requirements.
  • To ensure inventory is effectively managed.
  • To support key supply chain projects which will have an impact on strategy.

 

Key Responsibilities:

The main responsibilities of this Master Scheduler position will include:

• Design and maintain a 24 month Master Production schedule for assigned products to ensure fulfilment of customer demands. (Monthly activity)

• Liaise with a wide variety of internal and external work centres e.g. Production, labs, QA, warehouse to obtain buy in to schedule. Communicate the plan to all levels of the organisation.

• Drive performance improvements and be responsible for OSSCE Class A performance for assigned products

• Manage changes in demand and drive resolution of capacity constraints within the work centres.

• Manage inventory levels

• Provide technical coaching and support to scheduler buyers

• Influence and participate in Site and Global Supply Chain initiatives

• Facilitate market related changes encompassing all aspects of materials, packaging and production changes.

 

Required Experience:

The ideal candidate for this Master Scheduler position will have several years experience in a Pharmaceutical FDA regulated environment. An understanding of Supply Chain and Quality systems is also required.

To be considered for this Master Scheduler role you will have the following skills:

  • Excellent influencing and leadership skills
  • Ability to manage a variety of conflicting demands to meet clearly defined goals
  • Strong communication skills (oral and written)
  • Ability to interact effectively at all levels of the organisation both internally and externally e.g. Contract Manufacturers
  • Discipline to meet deadlines

 

Desirable Skills:

  • Experience in Scheduling/Planning or related function
  • Knowledge of OSSCE processes e.g. MRP
  • Previous experience in project management/ leading change
  • Supplier management experience

 

Apply Now

For more information or to apply for this Master Scheduler position, please contact Russell Oakley at CK Science on 0114 2839956 or email roakley@ckscience.co.uk. Entitlement to work in the EEA is essential.  Pleas quote ref: SH21292 on application.

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QC Analyst Job (Pharmaceuticals) – Essex, UK

 CK Science are currently recruiting for a QC Analyst to join a multi-skilled team providing a full range of laboratory services based in Essex, UK.

The laboratory is responsible for the sampling of raw and packaging materials, analysis of raw/packaging materials and product, sensory evaluation, research and development.

 

Responsibilities:

As a QC Analyst you will undertake the more complex and advanced analytical methodology in GC, HPLC, FTIR plus other laboratory equipment and methodology to satisfy daily work schedules. You will undertake daily sampling/analysis activities and will ensure all work is carried out to GLP. It is also envisaged that you will be able to deputise for the Laboratory Services Manager as required.

 

Person Specification:

The ideal candidate for this QC Analyst position, you will be degree qualified (or equivalent) in Chemistry and will have experience of a wide range of analytical techniques including GC, HPLC and FTIR. A working knowledge of Syspro, Word, Excel and the day to day operation of the LIMS systems wouldbe highly advantageous.

 

Apply Now

For more information or to apply for this QA Analyst position, please contact Jason at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Entitlement to work in the EEA is essential. Please quote reference ST21191 in all correspondence.

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Phoenix Chemicals adds Fifth Siemens Control System

As reported by The Engineer, the Wirral-based chemical and pharmaceuticals intermediaries manufacturer, Phoenix Chemicals is planning to extend its process control with Siemens Industry Automation to introduce a fifth PCS7 system.

The main focus of Phoenix’s centre on the production of API’s (active pharmaceutical ingredients) for the competitive pharmaceutical industry.

Since 2002, Siemens have already installed four PCS7 systems on a number on a number of continuous product processes at the company and now plans to add a fifth in the future.

The main benefit of the technology is that it means that processes can be readily and speedily re-configured for different products – this meeting ongoing customer needs in a shorter time scale. This is critical in the fast-moving and innovative pharmaceutical industry.

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Process Improvement Scientist Job – Merseyside, UK

Our client, one of the world’s largest research-based pharmaceutical companies are looking for a Process Improvement Scientist to join their team based in Merseyside.

As Process Improvement Scientist, you will be overseeing the technical performance and compliance of the production processes. This role will be key in identifying and resolving process performance with a clear and focused improvement remit.  Please note, this role is initially a 6 month contract position.

Key Responsibilities:

• Working with our operations Process Flow Teams to continuously improve process execution

• Ensuring changes comply with cGMP and environmental, health and safety regulations

• Overseeing the processes, identifying and eliminating causes of increased variability using a sound data driven methodology

• Investigating trends and ensuring correct countermeasures are implemented for any deviations resulting from the process performance

Required Experience:

• In depth knowledge and experience of manufacturing process operations and or engineering aspects gained by within a bulk pharmaceutical or food processing environment.

• Sound understanding of broader API processes with an emphasis on interactions with peers across the other product support groups.

• Experience in data management and statistical analysis of process information to identify continuous improvement and improve reliability and capability.

• Demonstrated ability in problem solving within a multidisciplinary environment to meet agreed timelines.

• Ability to interact with process technicians, engineering, analytical support and other operations support personnel.

• Ability to communicate effectively and build relationships at all levels in the organisation.

• Ability to operate in a cGMP environment and produce documentation to cGMP standards

Essential Skills:

• Degree in scientific or engineering discipline and experience gained within a bulk API manufacturing environment

• Demonstrated troubleshooting skills

• Interpersonal and influencing skills

• Proven ability to understand and analyse process data

Desirable Skills:

• Hands on experience in a Process Engineering would be a distinct advantage (but not essential), a keen interest in scientific or engineering development and six sigma experience would be beneficial.  You must be available at short notice to commence employment as the role is a CONTRACT role and the need is immediate.

Apply Now

For more information or to apply for this Process Improvement Scientist position, please contact Russell Oakley at CK Science on 0114 283 9956 or email roakley@ckscience.co.uk. Entitlement to work in the EEA is essential.  Please quote ref: SH20856 on application.

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Fermentation Scientist Job – Merseyside, UK

Our client, a research-based pharmaceutical company based in Merseyside is currently looking for a Fermentation Scientist to join their Fermentation Science & Technology Group. This position is a 6 month contract role.

Key Responsibilities:

The successful candidate for this Fermentation Scientist position will provide technical support to Fermentation Operations with the objective of maintaining and improving product quality, yield and throughput in line with business plan and quality commitments.

Key aspects of this Fermentation Scientist role include:

• Analyse production data to monitorand improve process performance. Use of data to make sound decisions.

• Ability to problem solve and trouble shoot manufacturing issues. Investigate and complete deviations.

• Identify and implement process improvement initiatives. Generate and complete change control documentation.

• Work closely with the Fermenter Team and other manufacturing and support functions to resolve day-to-day issues and drive continuous improvement.

• Review and amend relevant documentation, including batch production records, process flow documents, standard operating procedures, bill of materials, etc.

• Write technical reports to capture key learning.

Required Experience:

Candidates for this Fermentation Scientist role should be educated to degree or post graduate degree level (MScor PhD) in a relevant Scientific or Engineering discipline. Experience of fermentation process operations and cGMP requirements would be advantageous.  You must be available for work at short notice as this is a CONTRACT position and the requirement is immediate.

Apply Now

For more information, or to apply for this Fermentation Scientist position, please contact Russell Oakley at CK Science on 0114 283 9956 or email roakley@ckscience.co.uk. Entitlement to work in the EEA is essential.  Please quote ref: SH20854 on application.

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Abbott Labs VP joins French pharma company

lab teamThe Executive Vice President of Abbott Laboratories, Olivier Bohuon, is leaving the company to join the French pharma company, Pierre Fabre Group.

The former president, Richard Gonazlez will step in, leading Abbott’s pharmaceutical division on an interim basis.

Abbott’s pharmaceutical division is responsible for the majority of the companies revenue which is mostly due to their rheumatoid arthritis and Crohn’s Disease injection, Humira. The pharmaceutical division generated $4.1 billion in sales for the first quarter of 2010

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