General Manager

Job Description

• Overseeing the sampling, testing, and analysis of raw materials, intermediates, packaging materials, in-process samples, and finished pharmaceutical products to ensure they meet quality specifications. Responsible for designing and executing planning of analysis (routine work, method validation and method transfer).
• Ensure all testing is performed in compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and releases and as per company goal.
• He should have sound experience and expertise in wet chemistry and instrumental analysis (e.g. HPLC, GC, UV, IR, DSC etc) on different type of dosage form (OSD and OS), Prefer to have knowledge of Raman spectroscopy and Ion Exchange chromatography.
• Planning and conducting stability studies of products to monitor product quality varies over time and ensure the study successfully proceeds as per ICH and FDA guidelines. He should actively participate in the FAR investigation with QA-RA.
• He is responsible for daily updates, commercial output, monthly sample status, training, monthly review meetings and co-ordination with all stakeholders to align the work as per requirements.
• Lead the departmental improvement programs to enhance the output and quality.
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• II. Documentation and data management:
• Ensuring that all testing data, results and procedures are meticulously documented and accurately recorded in analytical test data sheets and eLogbook’s.
• He shall have experience on SAP, eData management, eSTB and LIMS.
• Preparing detailed reports, audits and inspections for internal review and regulatory compliance.
• Developing, preparing, reviewing and updating SOPs to ensure they meet current requirements and proactively communicating with the AD team to align the availability of specification and test procedure for analysis.

• Manage the quality management system, including handling deviations, incidents, and out-of-specification (OOS) results. Leading root cause analysis and implementing effective CAPA to prevent recurrence.
• Overseeing the calibration, qualification and PM of all laboratory instruments and ensure calibration schedules are followed.
• Ensure all QC activities comply with relevant regulatory standards and guidelines such as US-FDA, EMA, ICH.
• Responsible for adherence to GLP, GMP, Health, Safety Environment system in Laboratory and responsible for facing the FDA Audit (US, MHRA, EU) individually.

• Supervising, training and mentoring QC-AMV staff and technicians on quality control procedures, best practices and safety guidelines.
• He should be self-driven, have the capability to make self-decision and be a good learner. Providing guidance to team members for improving the work quality and monitoring and reporting on key performance indicators (KPIs).
• Hire QC-AMV personnel to ensure effective performance.
• Ensure adherence to all company policies, industry regulations, and regulatory requirements.
• Collaborating and coordinating with cross-functional teams like QA, RA, AD, R&D, Purchase, Supply chain and PMI to proceed the allocated task with ownership and accountability.

• Master Degree of Science / Bachler or Master Pharma.
• In-depth knowledge of QC principles and expertise in all types of modern analytical instruments (HPLC, GC, UV, IR, DSC, Malvern PSD etc) with the ability to interpret complex data and generate insights. LCMS knowledge will add advantage.
• Strong leadership skills with a proven ability to motivate and develop team members. Exceptional problem-solving skills and a strategic mindset. Solid organizational and time management skills, with the ability to manage multiple projects and deadlines.
• Knowledge of Empower will be an added advantage.
• Should have good working experience in GMP and US-FDA/EU Audit faced.
• Should have skills to achieve deliverable tasks with minimum support for analysis.
• Should have excellent written and verbal communication skills, with the ability to present findings clearly and effectively

• The role is expected to manage the work in all shifts.
• If required, he might need to travel across locations of company on work priority as per company policy.
• Responsible for ensuring compliance with GLP, Health, Safety and Environment requirement.

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