Stallion Laboratories Pvt. Ltd., a leading WHO-GMP & USFDA-approved pharmaceutical formulation manufacturer since 1988, is expanding its regulated market footprint with its state-of-the-art Unit-II OSD facility (USFDA, UK-MHRA approved & proposed EU-GMP).
We are urgently hiring experienced professionals with mandatory working experience in USFDA-approved Oral Solid Dosage (OSD) facilities for critical QA, QC, ADL, QMS, LIMS & IT roles at Ahmedabad, Gujarat. Preferred local candidates only.
Current Openings – Stallion Laboratories Unit-II (USFDA OSD Facility)
| Sr. No | Department | Designation | Experience | Key Responsibilities |
|---|---|---|---|---|
| 1 | IT | Sr. Manager | 15–18 years | IT infrastructure, 21 CFR Part 11 & CSV compliance, audits, backup, system governance, vendor coordination |
| 2 | Analytical Quality Assurance (AQA) | AM / Deputy Manager | 10–12 years | Lead AQA, data integrity, audit readiness (QC, ADL, Micro), CAPA, method validation/transfer |
| 3 | QC – LIMS (Caliber LIMS) | Deputy Manager / Manager | 12–15 years | LIMS implementation, PQ, master data, instrument integration, training, data integrity |
| 4 | QMS | AM / Deputy Manager | 10–12 years | QMS elements (OOS/OOT/deviation/change control/APQR), CGMP/GDP/CLP compliance, Qezige & Thes knowledge mandatory |
| 5 | AMT (Analytical Method Transfer – QC) | Manager | 12–15 years | Analytical method verification/transfer for APUFF & CMO/CDMO, gap assessment, client communication |
| 6 | QC (Planning/Review/Audit) | Deputy Manager | 10–12 years | QC planning, sample allocation, OOS/OOT review, audit preparation, compliance tracking |
| 7 | ADL (Head – ADL) | AGM | 20+ years | Lead entire ADL department, method development, regulatory support, team & lab management |
| 8 | ADL | Manager | 12–15 years | Method development/validation, stability studies, impurity profiling, regulatory documentation |
Mandatory Requirement: Proven working experience in USFDA-approved OSD manufacturing facility is compulsory for all positions.
Qualifications & Skills Required
- Bachelor’s / Master’s in Pharmacy, Science, or relevant field
- Hands-on experience in USFDA, UK-MHRA, or EU-GMP audits
- Strong knowledge of 21 CFR Part 11, data integrity, CSV, ALCOA+
- Expertise in HPLC, GC, AAS, LIMS (Caliber preferred), QMS tools
- Excellent investigation, CAPA, and root-cause analysis skills
Why Join Stallion Laboratories?
- Work in a USFDA & UK-MHRA approved OSD facility with upcoming EU-GMP certification
- Fast-track career growth in regulated markets
- Competitive salary & benefits
- Exposure to global regulatory standards
How to Apply
Send your updated CV to: aarti.oberoi@stallionlabs.com Subject Line: “Application for [Designation] – [Department] – USFDA OSD Experience”
Application Deadline: 29 December 2025
Frequently Asked Questions (FAQs)
1. Is experience in USFDA-approved OSD facility mandatory? Yes – 100% mandatory. Candidates without proven experience in USFDA-inspected Oral Solid Dosage plants will not be considered.
2. Are non-local candidates eligible? Preference is strictly for local (Ahmedabad/Gujarat) candidates due to immediate joining requirement.
