QA Manager/QP – North Wales

Naynesh Mistry is recruiting for a QA Manager/QP to join a leading manufacturer of veterinary pharmaceutical and animal health products in North Wales on a permanent basis.

Main responsibilities in this role include leading the quality function to ensure all processes are carried out in compliance with internal, regulatory and statutory requirements. You will also be required to act as the primary QP and be responsible for the review of batch manufacturing records, process deviations, LIRs and disposition.

To apply for this position you should have extensive experience in quality assurance, quality control, compliance and/or manufacturing. The ability to work as on-site QP in accordance with Directive 2001/83/EC and Annex 16 of the Rules and Guidance for Pharmaceutical manufacturers and Distributors 2002 is also required.

For more information on this position, or to apply, click here 

 

 

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Qualified Person – West of London

Jason Johal at CK Science is currently recruiting for a Qualified Person (QP) to join a growing Pharmaceutical Parallel Importer based West of London on either a part time permanent or full time contract basis.

Responsibilities:

As a Qualified Person you will ensure:

  • Ensure that batches of medicinal product have been manufactured and assembled in compliance with the EU legislative requirements
  • Manufacturing Authorisation requirements for medicinal products have been met for the batch concerned
  • Principles and guidelines of GMP as interpreted in the EU Guide to GMP have been followed
  • Necessary quality assurance checks and tests have been performed, and account taken of the assembly and packaging conditions, including a review of records
  • Changes or non-conformances in assembly, packaging or quality control are dealt with correctly
  • Regular audits, self-inspections and spot checks are being carried out by experienced staff
  • All associated documentation has been completed and endorsed by suitably authorised staff

Qualifications:

The successful Qualified Person will have the following qualifications, skills & experiences:

  • QP Status ESSENTIAL
  • Auditing experience
  • Batch release experience
  • Compliance experience
  • Continuous improvement experience
  • Parallel Import experience (Desirable)

As the role is offered on either a part time or a contract basis you will need to be readily available to company staff for advice and discussion, and also be present during regulatory inspections and involved in communications with inspectors. You must also be readily available to participate in complaints investigations and recalls.

Benefits:

If successful for this Qualified Person job, you will be joining a rapidly expanding and ambitious company who in return are offering an attractive daily rate, an exciting working environment and career progression opportunities.

Jason Johal - Pharmaceutical Recruitment

Please contact Jason for more details.

How to apply:

Apply online:

To apply for this Qualified Person position please contact Jason Johal via email: jjohal@ckscience.co.uk or telephone: 01438 723 500.   Please quote reference ST25899 in all correspondence.

 

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Qualified Person QP in Tyne & Wear, Durham

Barney Smith at CK Science is recruiting for a QP to work at a pharmaceutical company based in the Tyne and Wear and County Durham area in a permanent role.

This is an excellent opportunity to join an established and successful pharmaceutical company with excellent benefits and overall package.

Qualified Person Job Description:

As a QP you will be responsible for setting up a new facility in terms of equipment, processes, staffing, manufacturing and all regulatory information regarding product release.

The QP role you will have the following skills and experience:

– Full QP qualification

– A proven track record in working in aseptic compounding or oncology based manufacturing environment.

How to Apply:

 

Qualified Person QP in Tyne & Wear, Durham - CK Science

Please contact Barney for more details.

Click here to apply online now >

For more information or to apply for this QP position please contact Barney Smith on 0191 384 8905 or email your CV and covering note to bsmith@ckclinical.co.uk. Please quote reference  DH24773 in all correspondence.

 

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Qualified Person Job – Herts

CK Science are working exclusively on an assignment for a Qualified Person to join a global Pharma company based in Hertfordshire.

The company work on discovery of new molecules both NCEs and NBEs, in the branded generics markets and they also market APIs. They employ 6000 people in over 80 countries and have twelve manufacturing facilities and five R&D centres across Europe, Asia, Africa and South America. They are currently selling products in over 70 countries and are one of the most exciting and expanding pharma companies in the world today.

Responsibilities:

This Qualified Person role is based in the Generics arm of the business and you will act as a QP in accordance with EU GMP to provide final certification/release along with Quality Assurance a Regulatory support. You will perform audits of third party providers in order to ensure EU GMP standards have been achieved and will support the internal audit programme to enable permanent inspection readiness. You will also provide QP GMP declarations in support of importation activities and will be expected to maintain an up to date awareness of regulatory issues.

Person Specification:

It is essential that you are a fully qualified QP and that you are experienced with final certification/release within the EU. Quality systems management, audit experience (internal and external) and a strong EU regulatory understanding are also essential for this role. A good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and importation would be advantageous.

The ideal person will have the experience and the confidence to interact with QA and Regulatory teams and will have the strength of character to guide teams of professionals. Generics QP experience would be adistinct advantage but applications from QPs that have had exposure to a broad range of activities are welcome.

This is a key role for the company and is a sign of their ambition for the future. The position is full time, permanent and it is envisaged that the role will be based on site.

Apply now

For more information, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST21673 in all correspondence.

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Qualified Person Job – Hertfordshire, UK

CK Science are working exclusively on an assignment for a Qualified Person to join a global Pharma company based in Hertfordshire.

The company work on discovery of new molecules both NCEs and NBEs, in the branded generics markets and they also market APIs. They employ 6000 people in over 80 countries and have twelve manufacturing facilities and five R&D centres across Europe, Asia, Africa and South America. They are currently selling products in over 70 countries and are one of the most exciting and expanding pharma companies in the world today.

Responsibilities:

This role is based in the Generics  arm of the business and you will act as a Qualified Person in accordance with EU GMP to provide final certification/release along with Quality Assurance a Regulatory support. You will perform audits of third party providers in order to ensure EU GMP standards have been achieved and will support the internal audit programme to enable permanent inspection readiness. You will also provide QP GMP declarations in support of importation activities and will be expected to maintain an up to date awareness of regulatory issues.

 

Qualifications and experience:

It is essential that you are a fully qualified QP and that you are experienced with final certification/release within the EU. Quality systems management, audit experience (internal and external) and a strong EU regulatory understanding are also essential for this role. A good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and importation would be advantageous.

The ideal person will have the experience and the confidence to interact with QA and Regulatory teams and will have the strength of character to guide teams of professionals. Generics QP experience would be adistinct advantage but applications from QPs that have had exposure to a broad range of activities are welcome. 

This is a key role for the company and is a sign of their ambition for the future. The position is full time, permanent and it is envisaged that the role will be based on site. 

This role is being handled exclusively by CK Science and we would be happy to discuss details further at your convenience.

 

Apply now

For more information or to apply for this Qualified Person role, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST21673 in all correspondence.

Apply online now!

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Qualified Person Job (QP) – South East, UK

CK Science is currently searching for a Qualified Person (QP) to join our client, a company which provides Clinical Trial services including import, secondary packaging, batch release and distribution of Advance Therapy Medicinal Products and other specialised IMPs.

This QP role is a 12 month fixed term contract that is a full time position but there maybe the possibility to work part time for the right candidate.

 

Key Responsibilities

The key responsibilities of this QP position will include:

  • To provide QP certification/release as required by technical agreements with clients.
  • To conduct internal and external audits.
  • To act as the primary contact point for Quality for major clients.
  • To maintain an up-to-date awareness of current legislation and contribute to QP politics.
  • To provide technical advice and support in the preparation of Technical Agreements to the Contracts and Proposals group.
  • To provide GMP training.

 

Skills and Experience:

The ideal candidate for this QP role will have the following skills and experience:

  • Pharmaceutical development experience
  • Experience in the management of Clinical Supplies
  • Knowledge of the regulatory processes for clinical trials.

 

Apply Now

For more information, or to apply for this QP position, please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST20740 in all correspondence.

 

Alternatively, click here to apply for this QP job online now.

 

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Contract Qualified Person (Biologics Experience) based in Hertfordshire, UK

My client provides Clinical Trial services including import, secondary packaging, batch release and distribution of Advance Therapy Medicinal Products and other specialised IMPs. They are currently looking for a QP with Biological experience to join a growing team at one of their UK sites in Hertfordshire.

Under the direction of the UK Quality Manager, the QP will be expected to support the IMP activities within their Bioservices division. The role has three primary functions, acting as a QP, technical contribution to the operation of Bioservices and conducting audits. Forming part of the ‘QP team’ the jobholder will support the QP certification activities, maintain an up to date awareness of current legislation and contribute to QP policies.

The ideal candidate will meet the EU requirements for Qualified Person status and it is essential that they have experience in Biologics. The ability to interpret regulatory requirements in a pragmatic manner to support both the client study needsand that of the business is also essential. Any experience in Biotech development, management of Clinical Supplies or the regulatory processes for clinical trials would be a distinct advantage.

It is envisaged that the requirement will be for 1-2 days per week and the position will be on a rolling contract basis. Please call for more information on the role. If you are successful after the first round of screening we will contact you within 5 working days. Entitlement to work in the EEA is essential.

If you would like to hear more about this role, please contact Jason Johal on 01438 723 500 or email jjohal@ckscience.co.uk, quoting reference ST19009 in all correspondence. Alternatively, to apply, please click here.

 

About CK Science

CK Science is the largest independent scientific recruitment company in the UK. Our team of specialist recruiters are here to help you achieve your career ambitions within the scientific industry. We actively offer you careers advice, help with writing your CV, assistance with interview preparation and up-to-date information about the industry. We pride ourselves on providing an honest, straight-forward and trustworthy service to both our clients and candidates.

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