Senior Quality Assurance Engineer within the Engineering Division at Qualco Group. Ensuring reliable solutions for clients through thorough quality assurance practices.
About the role
- Quality Assurance Principal Associate overseeing quality activities in external manufacturing for pharmaceutical company. Liaising with external partners to ensure regulatory compliance and product quality.
Responsibilities
- Serve as a liaison between CMs and Lilly.
- Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
- Escalate quality issues at CMs to Lilly QA management.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
- Provide quality oversight of Lilly/APIEM Quality Plans
- Coordinate and perform QA responsibilities of API shipments.
- Participate in regulatory inspection preparations with CMs.
- Provide on-site support during manufacturing events and inspections.
- Participate on the Technical Review Board
- Evaluate and disposition API batches, if required.
- Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
- Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
- Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
- Ensure all processes are in an appropriate state of control.
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
- Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, and computerized system validations.
- Participate in APR activities.
- Participate in projects to improve productivity.
- Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
Requirements
- BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- Previous GMP manufacturing experience in API manufacturing in a Quality Assurance role (minimum 5 years of GMP QA on the floor support)
- Minimum 10 years of experience in a Quality Assurance role in “big pharma” as the Market Authorization Holder for non-generic products.
- Demonstrated foundational knowledge of ICH and EMA regulations.
- Experience participating in internal, customer, and regulatory inspections
- Process Validation and Technical Transfer experience
- Fluent in English
Benefits
- No certifications required
- Must complete required training for API EM Quality Assurance
- Flexible work hours
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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