Manager/Assistant Manager - Quality Control and Microbiology

About the Company

Allrite Pharmaceuticals is a fully integrated pharmaceutical company recognized for its commitment to quality and customer satisfaction. It manufactures a diverse range of products including tablets, capsules, liquid orals, ointments, creams, cosmetics, food supplements, and external Ayurvedic medicines. The company operates four state-of-the-art facilities located in Baddi, each specialized in distinct dosage forms. These facilities are equipped with advanced and modern machinery to support large-scale production across all product segments.

Role and Responsibilities

• Oversee and manage Quality Control (QC) activities for chemical, instrumental, and microbiology laboratories.
• Conduct testing of raw materials, packaging materials, in-process samples, finished goods, stability samples, and water samples according to established specifications.
• Review and authorize analytical reports, lab records, Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), and product specifications.
• Operate and troubleshoot various analytical equipment such as HPLC, Gas Chromatography (GC), UV-Visible Spectrophotometer, FTIR, and dissolution apparatus.
• Supervise microbiological processes including environmental monitoring, water quality testing, and microbial limit tests.
• Investigate and manage Out of Specification (OOS) and Out of Trend (OOT) results, deviations, and implement corrective and preventive actions (CAPA).
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), data integrity principles (ALCOA+), and regulatory standards.
• Coordinate method validation, method transfer activities, and stability study protocols.
• Lead, mentor, and manage the QC team to ensure timely completion of testing and documentation tasks.
• Support internal audits, customer inspections, and regulatory agency audits.

Preferred Candidate Profile

• Possesses a Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm) or Science (M.Sc. in Chemistry or Microbiology).
• Has 8 to 13 years of professional experience in pharmaceutical quality control related to formulations.
• Demonstrates strong practical knowledge in chemical quality control, instrumental analysis, and microbiology.
• Experienced in handling major analytical instruments including HPLC, GC, UV-Vis Spectrophotometer, FTIR, and dissolution testing.
• Well-versed in cGMP, GLP, data integrity (ALCOA+), handling OOS/OOT cases, CAPA processes, and regulatory compliance requirements.
• Familiar with laboratory documentation management, stability studies, and audit preparedness.
• Exhibits excellent leadership, communication, and team management capabilities.
• Experience with Oral Solid Dosage (OSD) and/or ointment and cosmetic formulations is an advantage.