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QA Manufacturing Operations Expert
2 weeks ago
About the Role
The QA Manufacturing Operations Expert will be responsible for providing quality support for manufacturing operations, ensuring compliance with safety standards and SOPs.
About the Job
- This is a 24/7 shift role that requires strong organizational skills, including the ability to follow assignments through to completion.
- Excellent written and verbal communication skills are essential for this position.
- The successful candidate will have experience working in aseptic operations, protein formulation, vial and syringe filling.
- Knowledge of applicable Regulatory requirements and the ability to evaluate compliance issues are also required.
Key Responsibilities
- Perform all activities in compliance with safety standards and SOPs.
- Write, review and approve Standard Operating Procedures in accordance with Policies.
- Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
- Review and approval of deviations for closure ensuring compliance with appropriate documentation.
- Participates in customer complaint investigations.
- Provides training and advice to staff in order for them to perform their desired functions.
- Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill finish-related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
- Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
- Review and approve cGMP records ensuring compliance with appropriate documentation.
Requirements
- University degree.
- Engineering or Science related discipline preferred.
- Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Excellent written and verbal communication skills.
- Experience working with dynamic cross-functional teams and proven abilities in decision making.
- Strong organizational skills, including ability to follow assignments through to completion.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
- Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
