Quality Control Laboratory Manager

11 hours ago

Roorkee, India BADRIVAS BIOTECH PRIVATE LIMITED Full time

Company Description Badrivas Biotech Private Limited is dedicated to delivering high-quality healthcare solutions that positively impact lives. We specialize in manufacturing and distributing trusted pharmaceutical products with a strong emphasis on safety, efficacy, and excellence. Our teams in Production, Quality Assurance, and Quality Control uphold the highest standards at every step of the process. At Badrivas Biotech, we aim to empower health, improve lives, and create a lasting impact within communities through our reliable and innovative offerings. Role Description This is a full-time on-site role for a Quality Control Laboratory Manager based in Roorkee, Uttarakhand. The Quality Control Laboratory Manager will oversee the day-to-day operations of the laboratory, implement and monitor quality control processes, ensure compliance with regulatory standards, conduct analytical testing, and provide leadership to laboratory staff. Additional responsibilities include maintaining the functionality of laboratory equipment and collaborating with Quality Assurance teams to maintain high operational standards. Experience: 10–15 years Location: Roorkee, Uttarakhand Key Roles & Responsibilities: - Supervise and manage all QC laboratory activities — including testing of raw materials, in-process samples, and finished formulations. - Strong expertise in HPLC operation, troubleshooting, and method validation; experience with systems like Agilent and Water. - Review and approve analytical data, chromatograms, and test reports ensuring data integrity and regulatory compliance. - Manage analytical techniques such as GC, UV, IR, Dissolution, and Karl Fischer titration. - Ensure compliance with GMP, GLP, ICH, WHO, and other regulatory requirements. - Lead OOS/OOT investigations, implement CAPA, and conduct root cause analyses. - Prepare and maintain SOPs, STPs, validation protocols, and stability data. - Coordinate with QA, Production, R&D, and Regulatory Affairs for timely product release and process improvements. - Handle and face regulatory and customer audits, ensuring continual audit readiness. - Train, mentor, and evaluate QC staff to maintain technical excellence and productivity. - Oversee calibration, qualification, and preventive maintenance of analytical instruments. - Drive continuous improvement initiatives to enhance testing efficiency, accuracy, and compliance. - Required Skills & Competencies: - Hands-on expertise in HPLC and analytical method validation. - Sound understanding of pharma regulatory guidelines (GMP/GLP/ICH). - Experience in stability studies, impurity profiling, and release testing. - Proficiency in analytical documentation and LIMS/CDS software. - Excellent team management, communication, and leadership skills. - Detail-oriented with strong problem-solving and audit-handling capabilities.

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