Sr. Executive/Asst. Manager || QA || MNC || NOIDA

Key Responsibilities:

• Preparation, review, and control of Master Formula Records (MFRs) and Batch Manufacturing Records (BMRs).
• Identification, drafting, review, and periodic revision of Standard Operating Procedures (SOPs) across departments.
• Compilation and preparation of Annual Product Quality Review (APQR) reports.
• Preparation, review, and execution of Qualification & Validation documents (equipment, utilities, process, cleaning, etc.).
• IPQC management ensure in-process checks are conducted as per defined procedures and documented appropriately.
• Ensure timely product release as per defined process and quality requirements.
• Work on company-wide quality strategies aimed at reducing non-compliances, deviations, and improving GMP adherence.
• Plan, coordinate, and support periodic internal audits and ensure timely closure of audit observations.
• Review and maintain QA-related logs, change controls, deviations, OOS/OOT, CAPA, and other GMP documentation.
• Conduct and coordinate GMP and documentation training programs, maintain training records, and assess effectiveness.
• Coordinate with production, QC, and engineering departments for documentation updates and compliance improvements.
• Ensure all QA activities comply with Schedule M, GMP, and company quality policies.
• Support during regulatory audits and ensure readiness of documentation and records.
• Monitor documentation and compliance related to products manufactured at third-party / contract manufacturing sites, ensuring adherence to company quality standards and regulatory requirements.

Required Qualifications and Skills:

• B.Pharm / B.Sc / M.Sc
• 5–8 years of experience in Quality Assurance Documentation and IPQC management within a regulated pharmaceutical or homeopathic manufacturing environment.
• Knowledge of cGMP and regulatory guidelines (Schedule M / WHO-GMP).
• Familiarity with change control, deviation, CAPA, and audit management systems.

Requesting to Apply if you have experience in above JD

Email- ShubhamUpadhyay.Sanat@schwabeindia.com