This role encompasses various responsibilities including Incoming Material Release, Batch Release, Change Control, Event Management, Supplier Qualification, Annual Product Review, and Validation Compliance activities.
Your focus:
- Provide guidance and support to all departments to ensure alignment with specific quality system elements, emphasizing business, quality, and compliance objectives following the J&J Standard of Leadership behavior model.
- Collaborate with other departments to implement compliance systems efficiently.
What you will do:
- Review batch records and release materials to ensure adherence to GMP requirements.
- Administer event management systems, including reviewing and approving Events, Deviations, and Customer Complaints.
- Manage batch record design and approval processes.
- Administer the SAP Quality Management Module.
- Oversee site change control systems.
- Compile Annual Product Reviews.
- Support validation activities outlined in the Site Validation Master Plan.
- Review and approve validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
- Support system qualification and process validation activities.
- Review and approve SOPs, work instructions, and forms from other departments on behalf of Quality Assurance.
- Coordinate and assist in the preparation for regulatory and customer GMP inspections.
- Participate in New Product Introduction Teams.
- Conduct on-site and vendor facility GMP audits as needed.
- Conduct regular on-the-floor walkdowns to ensure adherence to GMP standards.
- Administer the site supplier approval process.
About the successful candidate:
- Excellent interpersonal skills and ability to collaborate effectively within a team.
- Customer-focused with innovative problem-solving skills.
- Strong written and verbal communication skills.
- Attention to detail with a results-oriented and performance-driven approach.
- Adaptability and flexibility in decision-making.
You will need:
- Bachelor's Degree in a scientific/technical discipline.
- 3-5 years of experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable about FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Demonstrated understanding and application of industry regulations related to quality, including those of FDA, IMB, EMEA, and other regulatory authorities.
- Experience in auditing external suppliers, contractors, and vendors.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.