Job Title: FDA Approved Officer
Department: Quality Assurance (QA) / Regulatory Affairs
Location: Ambernath / Dombivli
Reports To: QA Manager / Plant Head
Job Summary
We are looking for an FDA Approved Officer with experience in pharmaceutical, cosmetic, fragrance, FMCG, or manufacturing industries. The candidate will be responsible for ensuring compliance with FDA regulations, maintaining statutory documentation, supporting audits, and coordinating with regulatory authorities to ensure all manufacturing activities comply with applicable quality and regulatory standards.
Key Responsibilities
- Ensure compliance with FDA regulations and applicable GMP guidelines.
- Maintain and update all FDA-related documentation, licenses, and approvals.
- Coordinate with FDA inspectors and regulatory authorities during inspections and audits.
- Prepare, review, and maintain SOPs, validation documents, and compliance records.
- Ensure manufacturing, quality control, and quality assurance activities meet regulatory requirements.
- Handle product registration, renewals, and regulatory submissions as required.
- Conduct internal audits and identify areas for compliance improvement.
- Investigate deviations, non-conformances, and CAPA implementation.
- Provide regulatory guidance to cross-functional departments.
- Stay updated with changes in FDA regulations and ensure timely implementation.
Required Qualifications
- B.Pharm / M.Pharm / M.Sc. (Chemistry) / B.Sc. Chemistry or related discipline.
- FDA Approved Competent Person certificate/license is mandatory.
- Knowledge of GMP, GLP, FDA regulations, and quality management systems.
- Experience in documentation, audits, and regulatory compliance.
Experience
- 2–6 years of experience as an FDA Approved Officer or Regulatory/QA professional.
- Experience in pharmaceuticals, cosmetics, fragrances, or manufacturing industries preferred.
Required Skills
- Strong knowledge of FDA regulations and GMP requirements.
- Excellent documentation and record-keeping skills.
- Good communication and coordination abilities.
- Analytical and problem-solving skills.
- Attention to detail and regulatory compliance mindset.
- Proficiency in MS Office.
Salary
As per industry standards (based on experience).
Joining
Immediate joiners preferred.
Pay: ₹18,000.00 - ₹25,000.00 per month
Benefits:
Work Location: In person
