Sr. Officer / Executive – QC DRA

Job Description

Job Title: Sr. Officer / Executive – QC DRA Department: Quality Control / Drug Regulatory Affairs (DRA) Reporting To: DRA Manager / QC Head Employment Type: Full-time Experience Required: Minimum 2 Years Qualification: M.Sc. / B.Sc. (Science/Pharmacy stream preferred) Job Summary: We are seeking a motivated and detail-oriented Sr. Officer / Executive for QC DRA to support the preparation, compilation, and review of regulatory documents required for product registrations and regulatory submissions. The ideal candidate should have experience working in QC or DRA functions within a pharmaceutical manufacturing setup and should be well-versed with regulatory compliance requirements (domestic and international). Key Responsibilities:1. Dossier Compilation & Review: Assist in preparation and review of CTD / ACTD / eCTD dossiers for domestic and international regulatory submissions. Compile and verify quality-related documents including specifications, STPs, validation protocols, and COAs for submission. Coordinate with internal teams (QA/QC/Production/R&D) to collect and organize required data for regulatory filings. 2. Regulatory Documentation: Prepare and maintain Product Master Files (PMFs) and Site Master Files (SMFs) . Support submission of Annual Product Reviews (APRs) , and DMFs (Drug Master Files) as per regulatory timelines. 3. Compliance and Coordination: Ensure all documentation aligns with current regulatory guidelines (e.g., WHO, USFDA, MHRA, EU, TGA). Coordinate with external consultants or agents for country-specific dossier submissions. 4. QC Interface: Liaise with the QC team to obtain data such as method validation, stability studies, and analytical results required for regulatory submissions. Review analytical data and reports to ensure correctness and readiness for regulatory review. 5. Audits & Queries: Assist in addressing regulatory queries and deficiencies. Support audit preparations and participate in internal and external audits as required. Candidate Requirements: Education: M.Sc. or B.Sc. (Chemistry, Microbiology, Biochemistry, or related disciplines) Experience: Minimum 2 years of experience in Quality Control or DRA in a pharmaceutical company. Skills: Good understanding of ICH guidelines, regulatory documentation structure , and technical writing. Hands-on experience in document review , dossier compilation , and data coordination . Proficiency in MS Office and regulatory software tools (if any). Soft Skills: Strong attention to detail and data accuracy. Good communication and coordination skills. Ability to meet deadlines and manage multiple priorities. Work Schedule: 6-day working week (as per company policy) Job Types: Full-time, Permanent Pay: ₹20,000.00 - ₹28,000.00 per month Benefits: Flexible schedule Food provided Health insurance Paid time off Provident Fund Schedule: Day shift Morning shift Weekend only Supplemental Pay: Overtime pay Performance bonus Yearly bonus Work Location: In person