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SENIOR QA SPECIALIST/QP
Company:GILEAD SCIENCES LTD |
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Job Reference Number |
14566239 |
Client ID: |
RI/QP |
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Posted On: |
Feb 7 2012 |
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Location: |
CORK |
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Job Type: |
Permanent |
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Salary: |
COMPETITIVE/NEGOTIABLE |
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Benefits: |
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Main area of responsibility
Performs a variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality.
Key responsibilities/activities of the position
· Provides day-to-day guidance and training to other QA personnel as required.
· Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
· Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
· Particpates in deviation investigations and event review meetings
· May participate in and review product complaint investiagtions
· Responsibilities may include the final release for all manufactured products, if and only when appropriate Qualified Person status is listed on the appropriate Manufacturing Licence.
· Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
· May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
· May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
· Works with Research and Development and Validation during new product start-ups, and recommends key checkpoints for new products and processes.
· May assist or lead compliance audits as required.
· May interface with contract manufacturers to address documentation and compliance issues.
· Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Qualified Person
Main area of responsibility
To ensure that all product distributed from GSL has been manufactured, tested and released in accordance with the provisions of Current Good Manufacturing Practice (GMP) and with its marketing authorization(s) (MA).
Key responsibilities/activities of the position
- The QP is required to ensure that they are aware of, and that they comply with the specific responsibilities of the QP as stated in the following documents (at a minimum):
- Directive 2001/83/EC relating to medicinal products for human use.
- Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
- Eudralex Volume 4 Annex 16: Certification by a qualified person & batch release
- Eudralex Volume 4 Annex 13: Manufacture of investigational medicinal products
- Certifies batches for sale or supply (in compliance with the above regulations). Note: The Q.P. who certifies a finished product batch before release may do so based on their personal knowledge of all the facilities and procedures employed, the expertise of the persons concerned and of the quality system within which they operate. Alternatively they may rely on the confirmation (by one or more other Q.P.s) of the compliance of intermediate stages of manufacture within a quality system which he/she has accepted.
- Approves the following:
- Annual Product Quality Review
- Relevant Standard Operating Procedures
- Complaint Investigations
- Deviations (EQMS product and process events)
- Supplier Investigations (EQMS general investigations)
- Quality Agreements
- Attends and participates in the following meetings (at a minimum):
- Event Review
- Quality Systems Review
- Site QP meetings
- Maintains their knowledge and experience keeps same up to date in the light of technical and scientific progress and changes in quality management relevant to the products which he/she is required to certify.
- Attends the following, where possible:
- Irish Medicines Board GMP & Market Compliance Information Days
- QP Forums
- Knowledge
· Must have a complete understanding and application of QA principles, concepts, industry practices, and standards. .
· Must be able to provide solutions to moderately complex to semi-routine problems.
· Must have the ability to recognise deviation from accepted practice is required.
· Must be able to apply knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
· Must be able to exercise judgment within generally well-defined procedures and practices to determine appropriate action.
· Normally receives no instruction on routine work, general instructions on new assignments.
· Strong verbal, technical writing and interpersonal skills are required.
Education & Experience
Typically requires a BA or BSc degree and minimum 7 years of relevant experience in related field or a MA or MBA degree and minimum 5 years of relevant experience. - The QP must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
