Latest Pharma & Chem Jobs at Topiox Research
Job Title: Documentation Officer
Company Name: Topiox Research
Experience: 3 – 5 years
CTC: Open Budget (Hike on the current CTC)
Number of vacancies: above 1
Rounds of interview: 3 rounds Virtual
Qualification: BSc / M.Sc. In Pharmacy / Life Sciences / Chemistry
Location: Navi Mumbai
Job Summary:
We are seeking a Documentation Officer with a strong background in pharmaceutical documentation practices to support our R&D and QA/QC teams. The ideal candidate will be responsible for preparing, reviewing, controlling, and managing all technical documents as per regulatory and organizational requirements.
Key Responsibilities:
• Prepare and maintain technical documentation including SOPs, STPs, Specifications, Protocols, Reports (R&D, Analytical, Validation).
• Ensure proper version control and document archival in compliance with internal SOPs and regulatory standards (USFDA, EU, etc.).
• Coordinate with cross-functional teams (Formulation, Analytical, QA/QC, Regulatory Affairs) to ensure accurate and timely documentation.
• Manage change control documentation and ensure proper implementation.
• Assist in documentation for regulatory submissions (ANDA, 505(b)(2), CTD modules, etc.).
• Perform document reviews for accuracy, completeness, and compliance with applicable guidelines.
• Support audits and inspections by ensuring documentation readiness and traceability.
• Implement and maintain document control systems (manual or electronic like MasterControl, Veeva, etc.).
Who Can Apply
Candidates with a Bachelor’s or Master’s degree in Pharmacy, Chemistry, or Life Sciences and 3–5 years of relevant experience in documentation within R&D, QA, or Regulatory teams are encouraged to apply. The ideal applicant should have sound knowledge of ICH guidelines, GMP documentation practices, and pharmaceutical regulatory requirements. Proficiency in MS Office and document control systems is essential. Preference will be given to candidates with backgrounds in formulation, analytical development, or regulatory affairs.
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