Troikaa Pharmaceuticals is currently inviting applications for the position of Executive – Regulatory Affairs (Compliance).
This opportunity is ideal for professionals with 1–3 years of experience in Regulatory Affairs, Quality Control (QC), and pharmaceutical compliance, particularly those experienced in COA review, stability data evaluation, audit trail review, and OOS/OOT investigations.
If you are looking for Regulatory Affairs jobs in Ahmedabad, especially within a compliance-focused QC review function, this role offers exposure to finished products, in-process samples, stability studies, and microbiological documentation under regulated pharmaceutical standards.
Key Responsibilities – Executive Regulatory Affairs (Compliance)
The selected candidate will be responsible for regulatory compliance oversight and QC documentation review in accordance with GMP and regulatory guidelines.
1️⃣ Finished Product Review
- Review and approve Certificate of Analysis (COA)
- Verify electronic data review checklist and raw data
- Evaluate worksheets and working/reference standards
- Check instrument calibration status
- Confirm acceptance criteria as per specification and MOA
- Document and update compliance observations
2️⃣ In-Process Sample Review
- Review approved results and supporting raw data
- Evaluate QC instrument performance and calibration records
- Ensure specification compliance as per MOA
- Update regulatory documentation and observations
3️⃣ Stability Sample Evaluation
- Review stability COAs and trending reports
- Validate electronic data review checklists
- Assess compliance with ICH stability requirements
- Ensure documentation integrity and regulatory alignment
4️⃣ Microbiological & Trending Documentation
- Review microbiological reports
- Analyze stability and quality trend documents
- Approve regulatory documentation
5️⃣ Investigation & Compliance Oversight
- Evaluate OOS (Out of Specification) cases
- Assess OOT (Out of Trend) investigations
- Review laboratory deviations and lab incident reports
- Conduct QC instrument audit trail review
- Ensure data integrity compliance
Required Qualifications & Experience
- Experience: 1–3 years in Regulatory Affairs / QA / QC (Pharmaceutical Industry)
- Strong knowledge of:
- QC instruments (HPLC, GC, UV, etc.)
- Audit trail review
- GMP compliance
- Regulatory standards
- Data integrity practices
- Experience in handling COA approval and lab investigations
- Good understanding of finished products, in-process, and stability documentation
Preferred Skills
- Hands-on experience in regulatory compliance documentation
- Exposure to pharmaceutical manufacturing audits
- Analytical thinking for deviation investigations
- Familiarity with MOA verification and acceptance criteria validation
Job Details
- Role: Executive – Regulatory Affairs (Compliance)
- Industry: Biotechnology / Pharmaceutical
- Department: Legal & Regulatory
- Employment Type: Full-Time, Permanent
- Location: Ahmedabad, Gujarat
- Experience: 1–3 Years
Salary & Benefits
- Estimated Salary Range: ₹4,20,000 – ₹6,50,000 per annum (based on experience and industry standards in Ahmedabad pharma market)
- Exposure to regulated pharmaceutical compliance environment
- Opportunity to work with cross-functional QC, QA, and regulatory teams
- Career growth in regulatory affairs and data integrity domain
How to Apply
