Senior Global QA Specialist- 6 Months
Office based in Hampshire
My client has an immediate need for a capable Senior Global QA Specialist-for a initial period of 6 Months.
Your primary responsibility for this role is contractor oversight of API manufacturing. This includes participation in team meetings, product release, investigation approval, auditing of contract manufacturing sites, negotiation of quality technical agreements, validation review/approval, etc.
Since our^client's formation just over 25 years ago, they have become one of the world's leading specialty Bio-pharmaceutical companies, but despite their growth, they remain true to the purpose that inspired them from their early days to help people with life-altering conditions to lead better lives.
Summary of Responsibilities
Perform API batch record review/release
Review/approve deviations and investigations related to API manufacturing. Process/review/approve change controls related to our clients API's.
Review/approve contractor's validation and qualification protocols and reports related to API.
Generation and maintenance of Supplier QTA's (Quality Technical Agreements) Conduct contractor audits to assure compliance to GMPs, regulatory filings (DMF, NDA, MAA, etc.), FDA, EU, and other applicable regulatory guidelines
Review and Approval of Contractor Change Controls and Deviations Generation and Approval of our clients Development Change Controls Generation and Maintenance of^Developmental QTA's for early stage API's
Timely review and Approval of Master Batch Records
Timely review and Approval of Stability Protocols
Essential Skills & Qualification
B.S. in a scientific discipline.
Minimum 5 years of GMP experience.
Minimum 3 years of QA experience with some responsibilities in product release, validation, auditing investigation assessment.
Strong analytical background preferred.
Experience in API manufacturing and Manufacturing of Developmental /Clinical^API's.
Willingness to travel globally if required.
Software Competence: MS Office,
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: No
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 6 Months
Location: Office Based access near the M3
Plan Start Date: Late August 2012
Quality Assurance, Audit, Inspection, CAPA, Findings, CQA, GMP, GCP, Qualified Person, QP, Clinical QA, Auditor, GCP Inspection, PVG Inspection, Regulatory
Assigned Consultant: Avril Horn at CSL Recruitment on 01932 228 928
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and^expected salary/day rate if you are a new candidate.