Quality Assurance Manager for Pharmaceutical Packaging

Job Description

We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility.

The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada).

Overall Responsibilities For Quality Operations And Initiatives, Including

1. Quality Assurance management:
2. Documentation control (master batch record, specification and method)
3. Batch record review and product disposition
4. Investigations, complaints, deviations, CAPAs, APRs
5. Production and Pharmaceutical Development support
6. APRs, GMP training and SOP review
7. Validation / qualification documentation review and approval
8. QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
9. Develop, maintain, and enhance training programs and systems
10. Driving key compliance initiatives such as Training Program Enhancements, Quality Documentation System Enhancements, and other identified initiatives.
11. Must be able to move about the facility
12. Experience with FDA Audit
13. Extensive knowledge of US and EU current Good Manufacturing Practices
14. Experience with a CDMO would be preferable

In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for:

1. Quality Compliance management:
2. All audits, internal, external - regulatory, client, and vendor
3. Vendor management program
4. QA Agreements with clients & contractors
5. License renewals

Company Description: We are a pharmaceutical packaging company looking for someone who is proactive and willing to learn and grow.

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