QA Operations Specialist
3 weeks ago
Do you want to be involved with exciting pharmaceutical projects?
When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a QA Operations Specialist.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
1. Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records.
2. Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMP and company procedures.
3. Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Re-qualification and Periodic review, Site Maintenance & Calibration Program.
Desirable Experience:
1. Extensive relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
2. This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
3. Experience working on manufacturing shop floor.
4. Familiarity with GMP documentation review and/or shop floor auditing.
If this role is of interest to you, please apply now
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