Quality Control Manager At Viatris
Position summary:
Responsible for the QC laboratory functions (Chemical, Stability, raw material, Packaging & Microbiology & Microbiology) and the corresponding documentation to support the timely disposition of product.
Responsible for QC resource planning.
Key responsibilities for this role include:
Responsible for the QC laboratory functions (Chemical, Stability, raw material, Packaging & Microbiology) and the corresponding documentation to support the timely disposition of product.
The laboratory function encompasses raw material, packaging, in process, Stability and finished product testing.
Manage the overall Quality control disposition of incoming materials and finished products.
Review and approval of the entire SOP’s relating to Quality control tasks and ensure understanding and implementation of these SOP’s.
Responsible for closing the Gaps between PQS’s and QC and compliance practices.
Responsible for insuring implementation of data integrity program on laboratory level.
Establish, recommend, maintain and assure that consistent laboratory procedures and practices are followed in accordance with company policy and regulatory requirements.
Support laboratory colleagues in all aspects of their work to achieve the completion of tests and/or investigations in a timely manner as well as maintaining an updated knowledge base in the technical, operations, company policy and regulatory fields.
Facilitate continuous improvement in QC day to day operations and general systems and will actively support achievement of plant goals.
Responsible for QC resource planning including preparation of budgets and monitoring budget adherence. With QO manager.
Troubleshooting of the department problems.
Coaching and developing QC colleagues to achieving high performance.
Review and approve the protocol and the results of the Analytical Method Transfer Exercise (AMTE) locally (for the new analysts) and for other locations. Also he is responsible for receiving and implementing AMTE for the new manufacture product to our site.
Implement all the stability (Ongoing and Accelerating stability programs). Review and approval of the stability reports.
Responsibility for compliance with Viatris Quality Standards.
Delegate for Site Quality Operation lead in case of his absence (if needed).
Delegate Finished goods Section Head, Microbiology Section Head, Incoming materials & Artwork Section Head or Quality Control Section Head (Stability and Methodology) in case of absence.
Delegate the appropriate person to sign any document submitted to regulatory authorities.
The minimum qualifications for this role are:
University graduate with science background, Green belt holder is a plus.
(8-10) years Industry/GMP experience is preferred in a related area.
cGMP & cGLP knowledge.
Good understanding of the pharmaceutical regulatory process.
Good command of English both written and spoken.
Logical way of thinking.
Management and decision-making skills.
High analytical skills.
Communication & high interpersonal skills.
High observation skills.
Problem solving skills.
Good planning skills.
Time Management skills