Join Stallion Laboratories: Exciting Opportunities in Our USFDA-Approved OSD Facility
Summary:
Stallion Laboratories Pvt. Ltd., a well-established pharmaceutical manufacturer approved by WHO-GMP and USFDA since 1988, is seeking experienced and highly motivated professionals to join our expanding team at our state-of-the-art Unit-II Oral Solid Dosage (OSD) facility in Ahmedabad, Gujarat. This facility is USFDA and UK-MHRA approved, with EU-GMP certification in progress. We are looking for dedicated individuals with mandatory experience in USFDA-approved OSD facilities to fill critical roles in QA, QC, ADL, QMS, LIMS, and IT. If you are a local candidate with a proven track record in the pharmaceutical industry and a passion for quality and regulatory compliance, we encourage you to apply.
About Stallion Laboratories:
Stallion Laboratories Pvt. Ltd. has been a trusted name in the pharmaceutical industry for over three decades, committed to manufacturing high-quality pharmaceutical formulations that meet the stringent standards of global regulatory agencies. Our state-of-the-art Unit-II OSD facility represents our continued investment in innovation and excellence, allowing us to expand our reach in regulated markets. We offer a dynamic and challenging work environment where employees can grow professionally and contribute to the success of a leading pharmaceutical company.
Current Openings – Stallion Laboratories Unit-II (USFDA OSD Facility):
We are currently seeking experienced professionals to fill the following positions:
| Sr. No | Department | Designation | Experience | Key Responsibilities |
|---|---|---|---|---|
| 1 | IT | Sr. Manager | 15–18 years | Manage IT infrastructure, ensure 21 CFR Part 11 and CSV compliance, manage audits, oversee backup and system governance, coordinate with vendors. |
| 2 | Analytical Quality Assurance (AQA) | AM / Deputy Manager | 10–12 years | Lead AQA activities, ensure data integrity, maintain audit readiness for QC, ADL, and Microbiology departments, manage CAPA, and oversee method validation/transfer processes. |
| 3 | QC – LIMS (Caliber LIMS) | Deputy Manager / Manager | 12–15 years | Lead LIMS implementation, perform PQ, manage master data, integrate instruments, provide training, and ensure data integrity within the LIMS system. |
| 4 | QMS | AM / Deputy Manager | 10–12 years | Manage QMS elements including OOS/OOT investigations, deviations, change control, and APQR. Ensure compliance with CGMP/GDP/CLP regulations. Knowledge of Qezige & Thes is mandatory. |
| 5 | AMT (Analytical Method Transfer – QC) | Manager | 12–15 years | Oversee analytical method verification/transfer for APUFF and CMO/CDMO projects, conduct gap assessments, and maintain effective communication with clients. |
| 6 | QC (Planning/Review/Audit) | Deputy Manager | 10–12 years | Manage QC planning, oversee sample allocation, review OOS/OOT investigations, prepare for audits, and track compliance metrics. |
| 7 | ADL (Head – ADL) | AGM | 20+ years | Lead the entire ADL department, oversee method development, provide regulatory support, and manage team and lab operations. |
| 8 | ADL | Manager | 12–15 years | Manage method development/validation, conduct stability studies, perform impurity profiling, and prepare regulatory documentation. |
Mandatory Requirement: Proven working experience in a USFDA-approved OSD manufacturing facility is absolutely essential for all positions. Candidates without this experience will not be considered.
Qualifications & Skills Required:
- Bachelor’s / Master’s degree in Pharmacy, Science, or a related field.
- Hands-on experience in USFDA, UK-MHRA, or EU-GMP audits.
- Comprehensive knowledge of 21 CFR Part 11, data integrity, CSV, ALCOA+ principles.
- Proficiency in using analytical instruments such as HPLC, GC, AAS, and experience with LIMS (Caliber preferred) and QMS tools.
- Excellent investigation, CAPA, and root-cause analysis skills.
Why Join Stallion Laboratories?
- Work in a USFDA & UK-MHRA approved OSD facility with an upcoming EU-GMP certification.
- Fast-track career growth in regulated markets.
- Competitive salary & benefits package.
- Exposure to global regulatory standards.
How to Apply:
Interested candidates are requested to send their updated CV to [email protected] with the subject line: “Application for [Designation] – [Department] – USFDA OSD Experience.”
Application Deadline: December 29, 2025
Frequently Asked Questions (FAQs):
-
Is experience in a USFDA-approved OSD facility mandatory?
Yes, it is 100% mandatory. Candidates without proven experience in USFDA-inspected Oral Solid Dosage plants will not be considered.
-
Are non-local candidates eligible?
Preference is strictly for local (Ahmedabad/Gujarat) candidates due to immediate joining requirements.