Senior QA Specialist, Vaccine Drug Product

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. Germany
Munich, Germany
Posting date: 28 Apr 2021
37117

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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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