Essential function(s) includes, but is not limited to:
Individual contributor is accountable for ensuring that all of Company products managed by EQA are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements.
The incumbent may also be accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and Company policies.
Additionally, the employee may also have the primary responsibility of Qualified Person according to EU GMP Annex 16 for batch certification and release confirming compliance for manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE
Responsibilities
Primary activities include, but are not limited to:
- Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
- Evaluate and/or release products where applicable by procedure with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations (if applicable); review and approve changes to master batch records or laboratory methods/specifications.
- Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
- Accountable for oversight of an EE involved in releasing of products for further processing with the assurance that the goods were produced or t