Dr.Reddy's - Urgent Openings in QMS & Engineering Quality Assurance
TEAM LEADER-QMS & ENGINEERING QUALITY ASSURANCE
Roles and Responsibilities
- Preparation of Annual Product Quality Reviews.
- To perform/review investigations arising from incidents, out of specifications, out of trend, Product failure, market complaints to identify the root cause and implement appropriate corrective and preventive actions.
- Coordinate and participate in preparation of risk assessment for new / existing Equipment's/systems/utilities/process.
- Initiation, evaluation, review and approval of Change controls.
- Responsible for review and approval of Computer system validation protocol and reports of GxP manufacturing equipment’s(SCADA,HMI,PLC) & Quality control systems.
- Preparation, Verification and Approval of Standard Operating Procedure’s /Standard.
- Familiar with Investigation report writing, root cause analysis, Corrective Action and Preventive Action for the incidents.
- Collation of information and coordinating the quality management review activities.
- Preparation, review and approval of quality notification trends and conducting the reviews.
- Ensure self-inspection is carried out as per Schedule and audit observation/non-conformances are followed up and closed in a timely manner.
- Handling of Product recall and Field Alert Report (FAR).
- Review and evaluate the service provider assessment.
- To participate and support continuous improvement projects.
- Review of all validation / Qualification protocols and reports with respect to URS/DQ/ IQ/OQ/ PQ for Facility, Area, Equipment, and Utilities.
- Responsible for review and approval Preventive maintenance schedule, Calibration schedule and facility maintenance schedule.
Desired Candidate Profile
Mandatory Skills:-QMS, APQR, Self Inspection, Engineering Assurance, Handling of Regulatory Inspection
Years of Experience:-7 to 10 Years
Education/Qualification:-B Pharm
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