Stallion Laboratories Hiring Manager/Sr. Manager for Quality Control – Analytical Method Validation in Ahmedabad

Join Stallion Laboratories Pvt. Ltd., a premier pharmaceutical formulation manufacturer founded in 1988, headquartered in Ahmedabad, Gujarat. Renowned for its oral solid dosage (OSD) forms like tablets and capsules, Stallion holds approvals from USFDA and UK MHRA, with proposed EU GMP certification for its Unit-II.

We’re urgently hiring a Manager or Senior Manager to lead our Quality Control (QC) department’s Analytical Method Validation (AMV) activities at our state-of-the-art Unit-II, supporting generics for regulated markets including the US, UK, EU, and Canada.

Job Opportunity: Manager/Sr. Manager – Quality Control (AMV)

We seek a seasoned professional to oversee AMV for OSD formulations, ensuring compliance with global regulatory standards. The role is based at Unit-II, a USFDA and UK MHRA-inspected facility, poised for EU GMP certification, driving Stallion’s expansion into high-compliance markets.

Position

• Manager / Senior Manager

Department

• Quality Control – Analytical Method Validation (AMV)

Qualification

• Master’s degree or higher in Chemistry, Pharmacy, or related field (e.g., Analytical Chemistry)

Experience

• 10+ years in pharmaceutical QC, with significant expertise in AMV
• Experience in USFDA- or UK MHRA-approved OSD facilities preferred

Job Location

• Unit-II, Gallops Industrial Park-2, Sarkhej-Bavla Road, Ahmedabad, Gujarat – 382220

Number of Openings

• 1

Key Responsibilities

• AMV Management:
  • Oversee validation, verification, and transfer of analytical methods for OSD products
  • Develop protocols for assays, dissolution, and impurities using HPLC and GC
  • Ensure methods align with ICH Q2(R1), USP, BP, and EP guidelines
• Documentation:
  • Review and approve AMV protocols, reports, and SOPs
  • Maintain GLP-compliant records for ANDA filings and audits
• Regulatory Compliance:
  • Adhere to cGMP and GLP standards
  • Support ANDA and dossier submissions for US, UK, and EU markets
• Team Leadership:
  • Mentor a team of 5-10 QC analysts, providing training on analytical techniques
  • Foster a culture of quality and precision
• Deviation Resolution:
  • Investigate OOS and OOT results, implementing CAPA to prevent recurrence
  • Ensure robust root cause analysis for lab deviations
• Cross-Functional Support:
  • Collaborate with R&D for method development and Production for batch release
  • Work with QA to ensure seamless analytical support
• Audits & Inspections:
  • Lead AMV discussions during USFDA and UK MHRA inspections
  • Address findings from internal and vendor audits
• Innovation:
  • Stay updated on advancements like UPLC and QbD
  • Drive continuous improvement in AMV processes

Key Skills

• Expertise in AMV for OSD per ICH Q2(R1)
• Proficiency in HPLC, GC, UV-Vis, FTIR, and dissolution testing
• Strong knowledge of cGMP, GLP, USP, BP, and EP
• Experience with LIMS and QMS (deviations, CAPA)
• Leadership and mentoring skills for QC teams
• Familiarity with ANDA filings and regulatory audits
• Problem-solving for OOS/OOT investigations
• Excellent communication for cross-functional and regulatory interactions

Salary

• ₹15-25 Lakhs/year (competitive, based on experience)

Why Join Stallion Laboratories?

Stallion Laboratories employs 500+ professionals and exports to 20+ countries, including the US, EU, and Africa. Our Unit-II, inspected by USFDA and UK MHRA in 2023, achieved its first ANDA approval for Levetiracetam tablets, marking a milestone in regulated markets.

Rated 3.5/5 on AmbitionBox for job security, Stallion emphasizes zero-defect manufacturing and total quality management. Employees value learning opportunities in a GLP-certified environment but note challenges like a 5.5-day workweek and occasional long hours.

Key Benefits

• Lead AMV in a USFDA-approved facility
• Support global ANDA filings for high-value markets
• Work with advanced analytical tools like HPLC and LIMS
• Mentor a skilled QC team in Ahmedabad’s pharma hub
• Contribute to Stallion’s EU and Canada market expansion
• Join a 36-year legacy with ISO 9001:2015 certification

How to Apply

Email your CV to vipul.brahmbhatt@stallionlabs.com with subject “Manager/Sr. Manager – QC AMV – Ahmedabad”. Include:

• Educational certificates (Master’s/Ph.D.)
• Experience letters and last 3 months’ payslips
• Aadhar and PAN cards
• CTC breakdown and notice period Be prepared to discuss AMV protocols, OOS investigations, and USFDA/MHRA audit experiences. Stallion Laboratories does not charge recruitment fees; verify communications via @stallionlabs.com emails. Immediate joining is preferred.

About Stallion Laboratories

Stallion operates three manufacturing units, with Unit-II (Ahmedabad) and Unit-III (Akola, EU GMP-approved) leading OSD production. As a trusted CMO/CDMO, we serve markets like Myanmar, Chile, and Nigeria, with a robust domestic presence. Our focus on quality, evidenced by USFDA and UK MHRA approvals, supports our growth in regulated markets. Stallion’s commitment to innovation drives our pipeline of generics and CMO services.

Our Mission

• Deliver affordable, high-quality formulations
• Achieve zero-defect manufacturing with cGMP compliance
• Expand into EU and Canadian markets with global standards

Apply urgently to vipul.brahmbhatt@stallionlabs.com to lead AMV at Stallion Laboratories’ Unit-II, Ahmedabad. Drive pharmaceutical excellence for global markets with a trusted industry leader!