
Pharmaceutical Quality Assurance Specialist
2 weeks ago
The Quality Assurance Specialist plays a pivotal role in ensuring the quality and safety of pharmaceutical products. This professional is responsible for maintaining compliance with regulatory requirements, such as EU Guidelines for Good Manufacturing Practice (GMP) and Annex 16.
This position demands expertise in quality assurance practices within a regulated environment to guarantee product integrity and safety. The successful candidate will oversee the entire production process, from manufacturing to testing, to ensure that every batch meets the highest standards.
Key Responsibilities:
- Ensure adherence to EudraLex Volume 4 EU Guidelines for GMP and Annex 16 requirements.
- Certify that each batch is manufactured and inspected according to relevant laws and regulations.
- Oversee the disposition of bulk products, determining release or rejection based on manufacturing and testing data.
- Assess and resolve day-to-day quality issues to ensure products meet quality and safety standards.
Qualifications:
- Necessary: Bachelor's degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry.
- MSc in Industrial Pharmaceutical Science or equivalent recognized for QP status under Directive 2001/83/EC, Article 49.
About Our Organization:
We are an equal opportunity employer committed to operating with integrity, driving innovation, and serving our community.
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