Key Responsibilities
Batch Manufacturing and Batch Packaging Records (BMR & BPR):
Review and approve BMRs and BPRs to ensure compliance with GMP standards.
Maintain accurate and complete documentation of manufacturing and packaging processes.
Coordinate with the production team to address discrepancies and deviations.
Master Formula Records (MFR):
Prepare, review, and approve MFRs to ensure alignment with regulatory and company standards.
Ensure the implementation of approved MFRs in production processes.
Quality Management System (QMS):
Implement and maintain QMS as per regulatory guidelines.
Handle deviations, change controls, CAPA (Corrective and Preventive Actions), and risk assessments.
Conduct regular internal audits and ensure timely closure of audit observations.
Standard Operating Procedures (SOPs):
Draft, review, and revise SOPs for various QA activities.
Train relevant staff on SOPs and ensure compliance.
Stability Studies:
Plan and execute stability studies in accordance with regulatory requirements.
Review stability protocols, analyze data, and prepare reports.
Process Validation:
Oversee process validation activities, including preparation and review of validation protocols and reports.
Ensure validation studies comply with regulatory requirements and company policies.
Equipment and Process Qualification:
Manage qualification activities for equipment, utilities, and processes (DQ, IQ, OQ, PQ).
Ensure all qualifications are documented and meet compliance standards.
Summary of Product Characteristics (SmPC):
Prepare and review SmPC documents for regulatory submissions.
Ensure accuracy and compliance with local and international regulatory standards.
Regulatory and Compliance:
Ensure all QA activities comply with GMP, GLP, and other regulatory guidelines.
Liaise with regulatory authorities and prepare for external inspections and audits.
Training and Development:
Conduct regular training sessions for staff on quality standards and compliance.
Keep updated on new regulatory guidelines and best practices in the QA field.
Qualifications and Skills
Educational Qualification: Bachelor's/Master's degree in Pharmacy, Biotechnology, Chemistry, or a related field.
Experience: Minimum [1] years of experience in a pharmaceutical QA department.
Key Skills:
Strong understanding of GMP, ICH guidelines, and regulatory requirements.
Proficiency in documentation and report writing.
Attention to detail and problem-solving abilities.
Excellent communication and leadership skills.
Pay: ₹180,000.00 - ₹300,000.00 per year
Work Location: In person
