Senior QA Engineer - External Manufacturing

Description

Key Responsibilities:
• Oversee and manage the quality assurance activities for external manufacturing partners.
• Ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards.
• Conduct regular audits of external manufacturing facilities to assess compliance and identify areas for improvement.
• Review and approve quality documentation, including batch records, deviation reports, and change controls.
• Collaborate with cross-functional teams, including regulatory affairs, supply chain, and R&D, to ensure quality issues are addressed promptly.
• Provide guidance and support to external manufacturers on quality-related matters.
• Develop and implement quality improvement initiatives to enhance manufacturing processes and product quality.
• Stay current with industry trends, regulations, and best practices related to medicinal drug manufacturing.

Qualifications:
• Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.

Advanced degree preferred.
• Minimum of 5 years of experience in quality assurance within the pharmaceutical or biotechnology industry, with a focus on medicinal drug manufacturing.
• In-depth knowledge of GMP regulations and guidelines (e.g., FDA, EMA, ICH).
• Proven experience conducting audits and managing quality assurance activities with external manufacturing partners.
• Strong analytical and problem-solving skills, with the ability to identify and address quality issues effectively.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
• Detail-oriented and highly organized, with the ability to manage multiple priorities and meet deadlines