Optimus Drugs Pvt. Ltd., a leading Active Pharmaceutical Ingredients (API) manufacturer and part of Sekhmet Pharmaventures, is hiring a DQA-API Executive for its R&D Centre in Pashamylaram, Sangareddy, Hyderabad, Telangana. Established in 2004, Optimus operates USFDA/EDQM-approved facilities, exporting APIs (e.g., Pregabalin, Bosentan) to 40+ countries with ₹500–1,000 Crore revenue.
Rated 3.5/5 for job security on AmbitionBox (120+ reviews), it scores 3.2/5 for work-life balance due to shift demands. The role offers ₹4–7 Lakhs per annum (Indeed estimates). Male candidates with API experience are invited! Apply by May 20, 2025.
Application Details
- Location: Optimus Drugs Pvt. Ltd., Plot No. 64, Survey Number 144/Part, EPIP, Pashamylaram (V), Sangareddy, Hyderabad, Telangana 502307
- Application Method: Email CV and portfolio to hr4@sekhmetpharma.com, subject: “DQA-API Executive – Pashamylaram.”
- Deadline: May 20, 2025
- Contact: hr4@sekhmetpharma.com, +91-8455-238109
- Website: www.optimuspharma.com
Notes:
- Fraud Alert: Optimus does not charge fees. Verify via www.optimuspharma.com or info@optimuspharma.com.
Why Join Optimus Drugs?
Optimus’ Pashamylaram R&D Centre, a USFDA-compliant facility, supports API development with advanced analytical labs (HPLC, GC, LC-MS). With 1,500+ employees and 40+ US DMFs, it’s a key player in Hyderabad’s pharma hub. Rated 3.6/5 for learning, it offers robust QMS training but faces feedback on slow promotions (3.3/5).
The company aligns with India’s $24.4 billion pharma export market, growing at 10% CAGR (Invest India). Benefits include health insurance and transport allowances.
Job Position: DQA-API Executive
Seeking a detail-oriented male professional to ensure quality assurance compliance for API analytical processes at Optimus’ R&D Centre.
Job Details
- Department: Development Quality Assurance (DQA) – API
- Position: Executive
- Qualification: M.Sc (Chemistry, Analytical Chemistry)
- Experience: 2–4 years in API quality assurance
- Vacancies: ~3–5 expected (based on industry norms)
- Location: Pashamylaram, Sangareddy, Hyderabad, Telangana
- Work Mode: On-site, shift-based
- Employment: Full-time
- Gender: Male only
Responsibilities
- Review equipment qualification, calibration, and validation reports (IQ, OQ, PQ) for analytical instruments (e.g., HPLC, GC, FTIR).
- Verify Specifications, Standard Test Procedures (STPs), and Certificates of Analysis (COAs) for reference standards and impurities.
- Conduct Genotoxic Impurities (GTI) and Nitrosamines risk assessments per ICH M7.
- Issue, archive, and maintain analytical documents, ensuring GLP and GDP compliance.
- Support QMS activities, including incidents, change controls, and deviation management.
- Review characterization data and ensure compliance with ICH guidelines (Q2, Q3D) and USP general chapters.
- Collaborate with R&D, QC, and manufacturing teams to address audit queries and ensure data integrity.
- Prepare for USFDA/EDQM audits by maintaining audit-ready documentation.
Required Skills and Qualifications
| Category | Details |
|---|---|
| Education | M.Sc (Chemistry, Analytical Chemistry) |
| Experience | 2–4 years in API quality assurance (DQA, analytical method validation) |
| Technical Skills | Review of IQ/OQ/PQ, HPLC/GC COAs, GTI/Nitrosamines assessment, QMS |
| Regulatory Knowledge | ICH Q2/Q3D/M7, USP general chapters, USFDA/EDQM guidelines, cGMP, GLP, GDP |
| Soft Skills | Analytical mindset, attention to detail, teamwork, time management |
| Preferred Expertise | Audit exposure, document archival, nitrosamines risk assessment |
Why This Role?
- Impactful Compliance: Ensure API quality for 40+ markets, with 90% of reviewed documents supporting DMF filings (industry trends).
- Skill Development: Master ICH M7, QMS, and USFDA audit processes, rated 3.6/5 for learning (AmbitionBox).
- Stable Employer: Optimus’ 20-year legacy, Sekhmet backing, and 12% revenue growth (2024) ensure stability, though promotions are slow (3.3/5).
- Competitive Pay: ₹4–7 Lakhs per annum with health insurance and allowances (Indeed).
How to Apply
- Prepare Documents: Update CV, highlighting 2–4 years in API DQA, HPLC/GC review, or GTI/Nitrosamines assessment, plus portfolio (e.g., sample COA reviews, SOPs), M.Sc certificates, payslips (last 3 months), Aadhaar/PAN copies.
- Submit Application: Email to hr4@sekhmetpharma.com, subject: “DQA-API Executive – Pashamylaram.”
- Include Details: Specify experience, current/expected CTC, notice period.
- Interview Prep: Study ICH M7 (Nitrosamines), Q2(R1), USP <1225>, and QMS processes (e.g., change control). Be ready to discuss a GTI assessment or equipment qualification review. Address promotion concerns diplomatically, as 40% report delays (AmbitionBox).
- Research Optimus: Visit www.optimuspharma.com for API portfolio and USFDA compliance.
Why Pashamylaram, Hyderabad?
Pashamylaram, part of Hyderabad’s pharma corridor, hosts Optimus’ USFDA-approved R&D and manufacturing units, contributing to Telangana’s $10 billion pharma sector (12% CAGR, Invest India). Accessible via NH-65, it offers 200+ QA jobs (LinkedIn) but limited urban amenities (AmbitionBox). Ideal for API quality assurance careers.
Contact Information
- Email: hr4@sekhmetpharma.com
- Phone: +91-8455-238109
- Work Address: Optimus Drugs Pvt. Ltd., Plot No. 64, Survey Number 144/Part, EPIP, Pashamylaram (V), Sangareddy, Hyderabad, Telangana 502307
- Corporate Office: Optimus Drugs Pvt. Ltd., 2nd Floor, Plot No. 73, Road No. 9, Jubilee Hills, Hyderabad, Telangana 500033
- Website: www.optimuspharma.com
- LinkedIn: Optimus Drugs Private Limited
Join Optimus Drugs by May 20, 2025, to ensure API quality at the Pashamylaram R&D Centre in Hyderabad. Apply now to drive pharmaceutical excellence!