Key Responsibilities:
Documentation and Compliance:
- Review batch manufacturing records (BMR) and batch packing records (BPR) for completeness and compliance with Good Manufacturing Practices (GMP).
- Prepare, review, and approve standard operating procedures (SOPs), work instructions, and specifications.
- Ensure compliance with pharmacopeial standards (USP, BP, IP, EP) and regulatory requirements (FDA, WHO, ICH, etc.).
Batch Release:
- Evaluate and approve batch documentation for the release of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs).
- Ensure that all deviations, change controls, and out-of-specification (OOS) results are resolved prior to batch release.
Audits and Inspections:
- Participate in internal audits, vendor audits, and regulatory inspections.
- Assist in preparing and implementing corrective and preventive actions (CAPA) based on audit findings.
- Maintain audit readiness and ensure compliance with all regulatory requirements.
Change Control and Deviations:
- Manage change control processes for materials, processes, and equipment.
- Investigate deviations and non-conformances, identify root causes, and implement CAPAs to prevent recurrence.
Validation and Qualification:
- Support validation activities, including process validation, cleaning validation, and analytical method validation.
- Ensure equipment and systems are qualified (IQ, OQ, PQ) as per protocols.
Training and Awareness:
- Provide training to production, QC, and QA teams on GMP, quality systems, and SOPs.
- Promote a culture of quality and continuous improvement within the organization.
Quality Systems Maintenance:
- Maintain and monitor quality systems such as deviation management, CAPA, and change control.
- Conduct periodic quality reviews and ensure timely updates of all quality-related documents.
Stability Studies and Risk Management:
- Monitor stability studies for APIs and ensure compliance with ICH guidelines.
- Conduct risk assessments for processes, equipment, and materials.
Qualifications and Skills:
- Education:
- Master's degree in chemistry or B. Pharmacy.
- Technical Skills:
- Strong knowledge of GMP, GLP, and regulatory guidelines.
- Familiarity with quality systems such as deviation management, CAPA, and document control.
- Understanding of process validation, equipment qualification, and analytical method validation.
- Soft Skills:
- Strong attention to detail and organizational skills.
- Effective communication and documentation abilities.
- Problem-solving mindset and ability to work collaboratively across departments.
Work Environment:
- Office and manufacturing site-based role with occasional exposure to production environments.
- May require flexible hours to meet production or audit schedules.
Key Performance Indicators (KPIs):
- Timeliness and accuracy of documentation review and approval.
- Compliance with GMP and regulatory requirements during audits and inspections.
- Effective resolution of deviations and implementation of CAPAs.
- Training effectiveness and adherence to SOPs by team members.
