Senior Manager-Quality Control

Job Description

Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) Ensuring compliance to laid down procedures (SOPs) & as per cGMP in all the departments Warehouse, Production, Engineering, QC &QA. Key Responsibilities (Performance Indicators) Ensure that the system for maintaining and calibrating critical equipment is established and implemented. Ensure that all procedures related to manufacture, packaging, testing, release and distribution are documented and are under document control Ensure that master batch production instructions are approved and documented and are under QC controls. Establish system for review of completed batch production and control records that will determine the release, approval or rejection of manufactured batches. Ensure that critical deviations are investigated and resolved through corrective and preventive (CAPA) actions. Ensure that validation master plan is documented and implemented. Ensure that validation protocols and reports are prepared, reviewed and approved. Ensure that all laboratory control records are maintained in compliance with guidelines. Inspection & approval of Raw material supplier & contract manufacturer. Review & approval of equipment qualification protocols & reports. Review & approval of change control Ensure that the stability data is available to support re-test & expiry dates and storage conditions. Ensure that internal audits are conducted and the findings are completed with corrective & preventive actions Investigation and resolution of customer complaints for corrective & preventive action Ensure that the findings of customer audits & regulatory audits are closed with corrective & preventive action Responsible for adherence to EHS policy. Training and development of team members. To ensure implementation of ISO 9000, ISO-14000, OHSAS -18000, TPM and WCM . To ensure implementation of 5S in lab and office. No. of Reportees 25-30 Qualification & Experience MSC(Chemistry/ Analytical) with 15-18 Yrs of experience in QC function of Chemical / API unit. Key Competencies ( Technical, Functional & Behavioral) Exposure to various regulatory and customer audits. Strong knowledge of quality systems / OOS investigations etc. Strong knowledge of cGMP and cGLP practices. ",