Commercial Quality Executive

Job Description

Role & responsibilities Job Purpose (State in one sentence the overall objective of the job) To ensure quality standards are followed for batch releases of imported products as per the local FDA, Schedule-M and Sandoz policies. To ensure timely batch releases. To ensure warehouses operations are effectively maintained for Quality Oversight. To ensure the adherence of TP to GMP requirement as per Sandoz policy & local FDA guidelines. Major Accountabilities (Describe the main results of the job to be achieved ) Release the batch in SHAPE & communicate to CWH inline with SOP. To prepare Audit Plan and Management of Self Inspection. To support Quality Escalation Management To Support Transport Assessment and Validations Warehouse QA Oversight and Quality Management To Support Complaint Management, Deviation and Action management. QM/GOP/SOP Implementation and Maintenance To Support Quality agreement preparation and review. To Keep warehouse in regulatory compliance Document and Data Management. To Support Quality Risk Assessment for Country organization To Support management Reporting To Support Product recalls. To support change control Evaluation and approvals Key Performance Indicators (Indicate how performance will be measured: indicators, activities) Overdue records and Actions NMT 5. Quality Risk Assessment Performance for Site. No. of Batch releases within target timelines No. of Recalls. QM/GOP/SOP Implementation Score NLT 95 % COMPANY : SANDOZ Exact Work Location : Sandoz Private Limited, 6th Floor, ithink Lodha business Park, Behind Viviana Mall, Chirak Nagar, Thane, Mumbai Shift timings : General 9.00 am to 5.00 pm Contract Tenure : 9 months Will Contract Extends : Extendable up to 3-6 Month Is any Transport provided from Sandoz : Candidate can avail Company transportation from Thane Railway station to office ( Predefined timings as per company) SHARE RESUMES TO NEDUNURI.SAIKUMAR@MANPOWER.CO.IN