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Senior Quality Operations Specialist
3 weeks ago
As a Quality Operations Specialist, you will be responsible for ensuring the quality and compliance of our manufacturing processes. This includes revising and reviewing Standard Operating Procedures (SOPs), reviewing executed Manufacturing Batch Records, and providing quality oversight.
Key Responsibilities:- Revise and review SOPs to ensure adherence to Good Manufacturing Practices (GMP) regulations
- Review executed Manufacturing Batch Records and Electronic Batch Records for accuracy and completeness
- Provide quality interpretation, answer queries, and resolve issues for the manufacturing team
- Participate in GEMBA walks and GMP walks to provide quality oversight and assurance
- Perform archival of Quality Operation related documents
- Support Quality operational tasks such as Improvements projects for Batch release
- Experience in a GMP-regulated pharmaceutical or biologics manufacturing environment
- Demonstrated knowledge of Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP)
- Strong attention to detail, ability to interpret and apply quality standards accurately
To be successful in this role, you should possess excellent analytical skills, strong communication skills, and the ability to work effectively in a team environment.
