Our client, a world leading Pharmaceutical Company in Indianapolis, IN is currently looking for a Senior Quality Engineer-Specialist / Pharma Manufacturing to join their expanding team.
Job Title: Senior Quality Engineer-Specialist / Pharma Manufacturing
Duration: 12 months contract, extendable up to 24 months
Location: Indianapolis, IN
Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.
You may participate in the company group medical insurance plan
With Quality oversight, support the review and approval of equipment and process qualification/validation protocols and reports
With Quality oversight, support the review and approval of process flow diagrams/product descriptions and subsequent master batch records - focus on large molecule cell expansion/bioreactor/purification manufacturing
With quality oversight, support the investigation related to manufacturing deviations
Review batch documentation provided by contract manufacturers (CMO) and responsible for product release in accordance to Company Supply Chain (JSC) procedures
Ensure all required testing and documentation are provided and met release requirements. Including but not limited to:
Review CMO Certificates of Conformance for batch release. Verify CMO certificates contain required information to confirm compliance of product to GMP, Company Specification and Quality Agreement requirements. Ensure all documents are in compliance with good documentation practice, data integrity, and accuracy of batch information, including but not limited to lot number, expiry date, within target ranges, etc..
Ensure required Certificate of Analysis and Certificate of Conformance from bulk manufacturers and external laboratories are included and met specification.
Ensure documentation review meets the requirements as specified for each product
Generate Company certificate of release
Maintain high level oversight of individual batch releases; able to give accurate, succinct updates on particular batch release status.
Alert Supervision of any nonconforming results, out of trend, or out of specification results.
Support supply chain logistics for on time shipment from CMO to Warehouse
Complete and pass all applicable training required for access to the systems
Complete and pass all applicable training for Good Manufacturing Practice and quality requirement training