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
Bachelor Degree in a scientific function, or equivalent degree level, with minimum of 6+ year healthcare industry experience
Experience in quality function in Biologics or Vaccine industry preferred
Previous experience in work environment under cGMP regulation highly desirable,
Must have strong ability to maintain high efficiencies and accuracy in data entry.
Strong proof reading skills to validate complex information and detect errors
Strong quantitative and analytic abilities to analyze and validate data
Ability to maintain and organized record file is essential
Strong computer skills in Excel, Word, Sharepoint
Ability to follow standard operating procedures and work instructions.
Good interpersonal, communication and organization skills. Ability to manage multiple and changing priorities required.
Detail oriented, dependable and motivated
Willingness to initiative to alert supervision when encountering aberrant data.