Job description  Position Summary   Sr. Manager - Quality Control -Pharma   This is position will be responsible for Quality Control Dept. Candidate required expertise in the Pharma Formulation Company. Candidate should have well versed in operation, maintenance, calibration; trouble shooting of various equipment's employed in QC laboratories. Candidate should have worked on instruments -HPLCs, Spectrophotometers, Autotitrators, GCs, dissolution testers, etc. Candidate should be aware of Quality documentation systems dealing with deviations, change controls, OOS, OOT, GDPs and having experience of documentation systems and procedures as per cGMP norms.   Key Accountabilities  - Generate, standardize and continuously improve Quality Control metrics across all supported businesses.  - To increase amount and validity of data collected from internal and external customers.  - Ensure accomplishment of Quality Control Department   - Drive Quality Control methodology and subsequent process improvements.  - Develop QMS regime to ensure continued and consistent Quality Control focus on as cGMP.  - Deliver timely Quality support to Distribution to achieve performance targets, including inbound, internal and external audits, product rework and Quality Alert response and resolution.  - Review and enhance the new product introduction process.  - Engage all Distribution Centre associates in Quality Control through promoting quality initiatives, addressing associates Quality Control needs and communicating Quality achievements.  - Drive inbound performance to L&D requirements, including conducting supplier audits, providing supplier scores and resolve product processing issues faced by Operations and Inventory.  - Manage Quality cost measures through staffing in adherence to budget and allocating costs by projects and business.  - Drive and address defect problems, product issues, supplier issues, quality working factories and communication with customers.   - Administering all QC independent and integrating technical, operations and system maintenance  - Proficient in developing & streamlining systems with proven ability to enhance operational effectiveness and meet operational goals within the cost, time & quality parameters  - Managing GLP compliance in the laboratory, good documentation practices and target orientation.  - Work planning & work allotment to the analysts as per priority to meet the requirement.  - Conducting review of all data & chromatograms of HPLC & GC analysis of Drug products (Pellets, Capsules & Tablet).  - Managing stocks of chemicals, glassware, chromatography columns & instrument spares as required.  - Investigating specification OOS/OOT results in finished products, stability samples and preparing report.  - Daily routine checks of log books, calibration records, temperature/humidity records.  - Efficiently worked on OOS, Change Control, Internal Audits, Analytical Method.  - Transfers, Qualification of Analyst, qualification of working standard and instruments, Good documentation practices.  - Exposure on regulatory audits likes USFDA, WHO, MHRA, FDA, etc.  Requirement   - B Pharma / M Pharma with 10 - 15 years of experience in Quality Control.  - Good knowledge Finished Dosage forms in a Regulated Environment.  - Well versed with cGMP, cGLP requirements of various Regulatory bodies.  - The experience of facing audits by National/ International agencies USFDA, WHO, MHRA, TGA, EU and ANVISA.  - Good knowledge on GMP, OOS OOT audits, investigations, compliance, quality management.

Gujarat

Senior Manager - Quality Control - Pharma 

Senior Manager - Quality Control - Pharma  ,Job Description for Senior Manager - Quality Control - Pharma  in HR Cornucopia Pvt Ltd. in  Gujarat for (10-15) years of experience. Apply Now!

Job Description for Senior Manager - Quality Control - Pharma  in HR Cornucopia Pvt Ltd. in  Gujarat for (10-15) years of experience. Apply Now!