Specialist External Quality Assurance

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Minimum degree in Science, Engineering or other relevant technical discipline (e.g., BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
Minimum of three years relevant experience in the pharmaceutical industry and/or biotechnology industry.
Thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
Able to communicate in English, both verbally and in writing.

Assure compliance with established policies/procedures of the Division and Corporation and comply with all applicable governmental regulations (GMP) both domestic and foreign.
Ensure the relevant quality-related activities associated with the technical transfer of packaging operations from one Contract Manufacturing Organization (CMO) to another.
REsponsible for change management, deviation management, equipment and process qualification and validation, auditing, quality agreements, contribution to the preparation of associated regulatory submissions.
Support CMC regulatory documentation requests.
Liaise with other stakeholders within EQA, External Manufacturing and other relevant stakeholders in the network involved with change control activities.
Evaluate and/or release products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations.
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 releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies.
Operate in a safe and efficient manner and in compliance with the Safety and Health Policy.