Senior QA Specialist, Vaccine Drug Product
- Employer
- Proclinical Staffing
- Location
- Germany, Munich, Bayern
- Salary
- Negotiable
- Start date
- 28 Apr 2021
- Closing date
- 12 May 2021
View more
- Discipline
- Quality, QA / QC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
An innovative pharmaceutical company located in Germany is in search for a talented Senior QA Specialist who will support Quality Assurance program for Vaccine Drug Product manufacturing operations. The potholder will be responsible for onsite QA oversight of CMO Drug Product manufacturing activities.Job Responsibilities
- Perform Person-in-plant (PIP) duties during manufacturing at CMO as needed.
- Work with Pharmaceutical Operations team and CMO to ensure that the batch records are reviewed and batches are ready for release in a timely manner.
- Participate in production planning meetings representing Quality Assurance.
- Coordinate QP certification of drug substance and drug product as defined in Quality/Technical Agreements.
- Work with Pharmaceutical Operations and CMO as the Quality Contact to resolve Quality issues during production, testing, warehousing and distribution.
- Demonstrated experience in investigations, change control, validation and audits.
- Onsite QA support for CMO inspections (interface between CMO backroom and backroom)
Skills and Requirements:
- Minimum 8 years of combined experience in the biopharmaceutical/pharmaceutical industry, with at least 5 years working in process and manufacturing GMP environment.
- Strong technical knowledge and hands on experience with manufacturing and process validation concepts and procedures in a GMP environment.
- Experience working with Biopharmaceuticals (CBER, FDA, EMA, MHRA) in a fast-pace environment.
- Prior experience conducting process transfers, scale up and validations.
- Working knowledge of CMO operations with respect to IMP/CTM manufacturing and process transfers.
- Knowledge of Global GMP regulations and guidelines.
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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