Production Manager Fill / finish

Merck Group; Livingston; On-site; GBP 80,000 - 100,000; Full time

Job description

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The Role

Provide leadership to ensure the smooth operation of assigned areas. Ensure compliance with cGMP, procedures, and quality standards.

Key Responsibilities:

1. Manage and organize production areas (Cleanroom vialing and processing; Whole Blood Control Production; Label and Packing operations) to align objectives with corporate and site business goals. Direct and oversee department staff in their duties and handle related HR activities, including interviewing, disciplinary actions, and performance management.
2. Conduct investigations of manufacturing operations, including deviation reports, and corrective action reports, within agreed timelines. Produce documentation according to established standards.
3. Ensure procedures are maintained in line with current ISO Standards and GMPs (SOPs, batch records, training records, etc.).
4. Collaborate with staff to implement process improvements and introduce new products and equipment into manufacturing.
5. Coordinate daily manufacturing activities with appropriate staff and related operations as needed.
6. Investigate daily manufacturing issues with processes and equipment and recommend resolutions in accordance with the Quality System; ensure accuracy and timeliness of approved implementation plans.
7. Train new employees in manufacturing operations and provide ongoing training on revised procedures such as run sheets, SOPs, and CAPAs. Complete timely performance reviews and mentor assigned staff as needed.
8. Assist the Quality Assurance department in investigating non-conforming products and out-of-specification reports.
9. Provide manufacturing input into the cost accounting database and ERP system (product, code, yields, pack sizes, completion dates, etc.).
10. Serve as a member of various plant committees related to manufacturing operations as requested.
11. Assume the role of Project Manager for new projects as required.
12. Review resources to ensure product realization and maintenance of the Quality Management System.

Who you are?

1. Bachelor's degree, diploma, or equivalent certification in biology, chemistry, biochemistry, or a related field; or relevant experience.
2. Minimum of 3 years of related experience in a manufacturing environment in a management role or applicable senior technical background.
3. Demonstrated leadership skills, including mentoring and coaching of staff.
4. General understanding of business principles and typical business practices.
5. Excellent verbal, written, and interpersonal skills, with the ability to work cross-functionally with other departments.