QA Manager
Vor 2 Tagen
Proclinical is seeking a QA Manager for External Suppliers to oversee quality management with external partners. This role focuses on ensuring compliance and enhancing performance in collaboration with contract manufacturers.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Review and approve GMP-compliant batch records and documentation for externally manufactured products.
- Prepare and approve documents for batch release by relevant authorities.
- Manage deviations, changes, and track CAPA measures and other QMS documents.
- Collaborate daily with external partners to maintain professional representation.
- Coordinate complaint handling with external partners and internal functions.
- Support preparation for regulatory inspections and audits at external partners.
- Coordinate documents required for regulatory registration.
- Manage Quality Agreements (QAGs).
- Assist in creating global quality metrics/KPIs for external partners.
Key Skills and Requirements:
- Degree in Pharmacy, Microbiology, Life Sciences, or a related field.
- Experience in Quality Assurance, Quality Oversight, or Regulatory Compliance in the pharmaceutical or biotech industry.
- Strong knowledge of GMP regulations.
- Excellent written and oral communication skills; ability to work in cross-functional teams.
- Interest in digital transformation and continuous improvement through data analytics and automation.
- Ability to work effectively in a fast-paced environment with minimal supervision.
- Detail-oriented, reliable, and a team player.
- Proficient in English.
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