Pharmacist

Pharmacist (Regulatory Affairs & Quality Assurance)

We are seeking a qualified and experienced Pharmacist to join our team, responsible for managing Regulatory Affairs, CTD compilation, DRAP documentation, SOP preparation, and Factory Quality Assurance documentation.

Key Responsibilities:

• Prepare, compile, and review CTD dossiers in accordance with DRAP requirements.
• Manage regulatory submissions, renewals, and responses to queries from health authorities.
• Develop, review, and update Standard Operating Procedures (SOPs) related to production, QA, and regulatory processes.
• Ensure compliance with cGMP and QA standards within the manufacturing facility.
• Maintain all Quality Assurance documentation, batch records, deviation reports, and validation records.
• Coordinate with production, QC, and management for regulatory audits and inspections.

Requirements:

• Pharm-D or equivalent qualification from an HEC-recognized institution.
• Minimum 5 years of relevant experience in Regulatory Affairs and QA documentation within a pharmaceutical manufacturing environment.
• Hands-on experience with CTD format, DRAP documentation, and regulatory submission procedures.
• Strong knowledge of pharmaceutical compliance, QA systems, and documentation standards.
• Excellent organizational and communication skills.

Job Type: Full-time

Pay: Rs60, Rs150,000.00 per month

Work Location: In person