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Quality Assurance
3 weeks ago
Job Summary: We are seeking an experienced QA Batch Record Review Consultant to join our team. The ideal candidate will bring extensive knowledge and expertise in quality assurance, particularly within the pharmaceutical and biotech industries. The consultant will be responsible for conducting thorough reviews of batch records to ensure compliance with regulatory requirements and industry standards, supporting the production of high-quality pharmaceutical products. This role requires a detail-oriented professional with a strong understanding of Good Manufacturing Practices (GMP) and the ability to work collaboratively with cross-functional teams.
Key Responsibilities:
Batch Record Review:
Conduct detailed reviews of batch records for completeness, accuracy, and compliance with GMP, SOPs, and regulatory requirements.
Ensure all discrepancies, deviations, and non-conformances are properly documented, investigated, and resolved before batch release.
Collaborate with manufacturing, quality control, and other departments to ensure batch records meet all quality and compliance standards.
Provide recommendations for improvements in batch record documentation processes.
Quality Assurance Support:
Assist in the development and implementation of quality assurance processes and procedures to enhance batch record accuracy and completeness.
Support internal audits and regulatory inspections, providing necessary documentation and responses related to batch record reviews.
Participate in risk assessments and CAPA (Corrective and Preventive Actions) related to batch record discrepancies.
Regulatory Compliance:
Stay current with industry regulations, guidelines, and best practices in the pharmaceutical and biotech industries.
Ensure all batch record review activities comply with FDA, EMA, and other relevant regulatory agencies' requirements.
Training and Development:
Provide training and guidance to manufacturing and quality teams on best practices for batch record documentation and review.
Develop and maintain training materials related to batch record review processes and regulatory compliance.
Qualifications:
Bachelor's degree in a related field (e.g., Chemistry, Biology, Pharmacy, Engineering) required; advanced degree preferred.
Minimum of 2 years of experience in quality assurance, with a focus on batch record review, within the pharmaceutical or biotech industries.
In-depth knowledge of GMP, FDA, EMA regulations, and other relevant industry standards.
Strong attention to detail with excellent analytical and problem-solving skills.
Ability to work independently and as part of a team, with strong communication and interpersonal skills.
Experience with electronic batch records (EBR) systems is a plus.
Preferred Skills:
Experience in a consulting role, providing QA support to multiple clients.
Familiarity with a wide range of pharmaceutical and biotech manufacturing processes.
Knowledge of risk management and CAPA processes.
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