This role will give an entrepreneurial, self-starting individual the opportunity to make the role their own and to build a successful & passionate team around them. The successful individual will be reporting into the Quality Director who is based in the US. No day will be the same with this role as the company have several different products ranges and work across several accreditations and regulations.
The key responsibilities and desirables are listed below:
- Management and leadership of a growing quality team.
- Monitoring of GMP compliance with recommendations for corrective measures; involvement and direct supervision in all area quality activities.
- Reviews and recommends approvals for deviations, QA holds, rework, and in-process adjustments. Investigates non-conformances, deviations and CAPA and elevates issues to MRB as needed
- Reviews and approves finished product specifications and raw material specifications.
- Reviews and approves master manufacturing and production batch records
- Signs as final product release for all components, raw materials, bulk and finished goods
- Audit suppliers as needed.
- Ensures collaborative process development, continuous improvement and problem solving with quality control, production, maintenance and warehouse
- Oversees the facility's calibration control program.
- Works with and supports Operation functions.
- Involved and is part of the FDA, NSF, TGA KFDA etc audit response team.
- Prepares reports by collecting, analysing, trending and summarising deviations, QA holds, rework, etc.; submits regular reports to Quality Assurance Director.
- Complies with FDA, cGMP and other requirements and enforcing adherence to requirements.
- 8 + years experience within the Food / Pharma / Med Device or Cosmetics industries.
- 3 to 5 years of supervisory experience required in QA environment
- Bachelors degree in any related scientific field
- Ability to perform and review all quality processes from receiving to shipping of product.
- Labelling experience would be highly beneficial
- Ability and knowledge in performing in-house audits, and potentially Supplier Audits
- Knowledge and experience with applicable FDA regulation, cGMP requirements and GLP requirements.
- Ability to write and implement standard operating procedures in the warehouse and corporate facilities.
- Ability to understand, monitor and review all Quality processes in the warehouse and corporate facilities
- Validation experience (equipment, process) would be highly desirable
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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