The position requires well developed supervisory, organizational, and project management skills. It is expected that the incumbent will supervise managers, group leaders and QC analysts and also work independently under minimal direction while accomplishing the timely completion of assignments. Good written and verbal communication skills are essential. Work activities will include, but are not limited to, participating in the reviewing routine testing results, preparing protocols and reports, performing OOS and deviation investigation, providing cGMP and technical development for the staff, and interfacing with other internal and partner departments relative to quality issues. The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities. Provide technical expertise, leadership to meet specified timelines. Overall Supervision of Quality Control laboratory.
Act as technical resource and train other analysts in areas of expertise and maintain the laboratory in an inspection-ready state all the time.
This position will interact with all other departments throughout the organization. Primary a
Develop, optimize, validate and troubleshoot analytical test methods as required.
Ensuring adequate facilities, Instruments, Trained Personnel, Approved procedures for testing of raw materials, Packaging materials, In-process, Finished Products and Stability testing Samples.
Ensuring the Qualification, Calibration, Preventive maintenance of Instruments/Equipments.
Draft written test procedures for new analytical methods. Review and Approval of Specifications, Standard Testing Procedures, Protocols for Stability Studies, Process Validation, Cleaning Validation, Analytical Method Transfer/ Validation/ Verification and Equipment/ Instrument Qualification.
Review and Approval of SOPs, SOIs, PMPs and all documents related to Analytical Instrumentation and ensure compliance.
Ensuring the Quality of gases (Compressed air, Nitrogen etc.), Pure steam, water (Raw water Purified water, Potable water, Water for injection etc.)
Ensuring the proper maintenance of samples for testing like API (Active Pharmaceutical Ingredients) Excipients, Packaging materials, In Process samples, Finished Products, Stability samples and Water samples as per their storage Condition in the respective designated places.
Monitoring the Analytical method transfer activities of drug substances, drug products and Excipients whenever required before taking exhibit batches
Monitoring the analysis of market complaint samples whenever required.
Ensuring Technical training (SOP and on job training) of all analysts, Continuing learning and Education and evaluation.
Ensuring implementation of updated procedures as per regulatory norms. Ensuring effective safety systems are implemented in the labs.
Reviewing the day to day activities of Quality control team to meet targets. Supporting all Regulatory and Customer Audits.
Procurement of new instruments and assist in budget planning both capital and operational.
Co-ordinating with all Internal & External Customers.
Recruitment of talents as per requirement.
Any other job duties assigned from time to time.
M.Sc/M.Pharm/Ph.D with 15 + years experience Basic understanding of cGMP and good documentation practices in pharmaceutical Industry
Understands SOPs, specs / STP and other documents commonly used.
Safety.SOI,PMPsKnowledge on all equipments in Laboratory.
Knowledge of Chemical reagents, analytical aids and glassware.
Knowledge in analytical method development, Validation and transfer.
Knowledge of regulatory requirements.
Conversant with quality Management system