Quality Assurance Principal Associate

Eli Lilly And Company

5 - 10 years

12 - 16 Lacs

hyderabad

Posted:1 hour ago| Platform:

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Skills Required

site management manager quality assurance networking pharma pharmacy cms healthcare life sciences gmp api manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

Basic Requirements :

Bachelor of Science 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

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