Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control. The path of success lies in its belief of creativity and no negotiation with the quality of work. Stallion Laboratories Unit-ll a USFDA & UK-MHRA approved facility and proposed to be EU GMP approved plant. With its approval, Stallion aims to enter regulated markets.

Seeking a highly skilled and experienced individual (Manager / Sr. Manager) to lead our Quality Control department’s Analytical Method Validation (AMV) activities. Candidate will be responsible for ensuring that all analytical methods used for testing pharmaceutical products are validated in accordance with regulatory requirements and industry best practices.

Key Responsibilities
• Oversee and manage all aspects of analytical method validation, verification, and transfer.
• Develop, review, and approve AMV protocols, reports, and related documentation.
• Ensure compliance with current Good Manufacturing Practices (cCMP), Good Laboratory Practices (CLP), and other relevant regulatory guidelines (e.g., ICH, USP, BP, EP).
• Lead and mentor a team of QC analysts, providing guidance and technical expertise.
• Investigate and resolve any deviations, out-of-specification (OOS), or out-of-trend (OOT) results related to analytical methods.
• Collaborate with R&D, production, and quality assurance departments to ensure seamless analytical support.
• Stay updated with the latest advancements in analytical techniques and regulatory expectations. Participate in regulatory inspections and internal audits, addressing any queries related to AMV. Drive continuous improvement initiatives within the QC laboratory, particularly in AMV processes.

Candidate Profile
• Masters degree or higher in Chemistry, Pharmacy, or a related scientific discipline.
• Extensive experience (typically 10+ years) in a pharmaceutical quality control laboratory with a significant focus on analytical method validation.

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