Compliance Assurance Specialist
Vor 2 Tagen
Overview:
Panda International: Your Partner in Quality AssuranceWe are a leading international company dedicated to providing high-quality services and products. Our commitment to excellence is reflected in our rigorous approach to quality assurance, ensuring that our customers receive the best possible results.
Job Summary:
Compliance Assurance SpecialistWe are seeking an experienced Compliance Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for supervising compliance and customer Quality Agreement activities for drug production.
- Establish and maintain Quality Agreements (QAA) in collaboration with Drug Product Services (DPS) teams.
- Act as the primary point of contact for Drug Product QA-related inquiries, topics, and customer complaints.
- Serve as the QA representative in project teams and customer meetings during technical transfers.
Key Responsibilities:
Compliance Assurance Specialist Responsibilities- Supervise compliance and customer Quality Agreement activities for drug production.
- Collaborate with DPS teams to establish and maintain Quality Agreements.
- Represent Quality Assurance in cross-functional teams and maintain interfaces with Manufacturing, QC, Support Functions, Project and Site Engineering.
- Support continuous improvement programs to enhance the Quality Management System for Drug Product.
To succeed as a Compliance Assurance Specialist, you will need:
- Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
- 5-10 years of relevant experience in Quality Assurance within drug production or pharmaceutical manufacturing.
- Strong knowledge of GMP regulations and compliance requirements.
- Experience in negotiating and managing Quality Agreements with external partners.
- Ability to assess and resolve quality-related issues, including deviations, complaints, and investigations.
- Proven ability to work cross-functionally with Manufacturing, QC, Engineering, and Regulatory teams.
- Excellent communication and stakeholder management skills.
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