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 (Sr. Manager / AGM) to lead our Production (Manufacturing)

Job Description• To look after day-to-day operations and planning of manufacturing and packing activity
• To lead and mentor the manufacturing and packing team for optimal performance for quality product delivery.
• Prior experience of facing minimum 5 US-FDA audits. Ensure compliances with USFDA, MHRA, EU CMP and other regulatory standards.
• To ensure Zero Data Integrity Issues across production area.
• Identify opportunities for continuous improvement (Productivity / Operation Excellence, System/ Process improvement initiatives, Cost reduction..)
• Facility/capacity expansion with identifying appropriate Equipment with Capex (URS, qualification and commissioning in time).
• Operation Management: To prepare and ensure to meet the daily, weekly and monthly plan.

• To ascertain each batch manufacturing with high standard of quality, within established stage wise yield criteria as well as final batch yield
• Timely coordination/collaborate with other functions/department to ensure seamless operation.

• All time readiness across the production and packing w.r.t. online documentation (QMS/Batch records etc.),
• Cleanliness, sanitization, status labeling, qualified personnel with well controlled and organized production activities.
• Audit compliances/CAPA submission with detailed investigation/evidences in time.
• To participate in manufacturing and packing feasibility evaluation with tech transfer/F&D team.
• Timely availability of BMR/BPR and review of Process validation, cleaning validation, hold time, stability protocol, risk assessment and change controls.

Candidate Profile
• Master’s degree or higher in Pharmacy, or a related scientific discipline.

• Extensive experience (typically 14+ years) in a pharmaceutical Production area.

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