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Senior Pharmaceutical Quality Assurance Specialist
2 months ago
Company: SRG, a leading recruitment company specializing in the science, engineering, clinical, pharmaceutical, food, and medical devices sectors.
Job Title: Qualified Person - Pharmaceutical Quality Assurance
Job Summary:
We are seeking an experienced Qualified Person to support our client, a well-established pharmaceutical organization, in ensuring the quality and compliance of their products. The successful candidate will have prior experience in pharmaceutical quality assurance and be familiar with EU regulations and guidelines.
Key Responsibilities:
- Adhere to the Orange Guide and Annex 16 – Certification by a Qualified Person and Batch Release guidelines.
- Review and approve Third-Party QA audit reports.
- Batch certification and release for licensed products manufactured on site by the company, the CMO in third countries, and for medical device and cosmetic products manufactured on site by the company.
Requirements:
- Prior experience in pharmaceutical quality assurance.
- Highly familiar with EU Directive 2001/83/EC, Article 49, and Human Medicines Regulations (as amended), SI 2012/1916, Schedule 7, Part 1.
About SRG:
SRG is committed to providing outstanding temporary, contract, and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
