Executive

Daily Plant round observations to identify the OFI/gap as per IMS/GMP requirements and their compliance action plan with plant manager for effective implementation of Quality management system /good practices in assigned pant/area.
- Issuance, retrieval, and control of BPRs/logbooks/Forms/Formats/Annexures in a harmonized way to get data integrity.
- Co-ordinate with plant, to verify operational SOP/BPR/Logbooks in line with current practices and control of all QA related documents and shop floor in their assigned plants/area.
- To check and assure that manufacturing operations /processes are performed step by step as per mentioned BPR/logbook in line with established SOP.
- Consistency of Process-Collection & compilation of operational data to develop the trend to know the process capability and ensure the consistency of process in terms of yield/purity/BTC/breakdowns etc.
- Sharing the process/product trend on monthly basis to relevant plant managers for their further action plan/improvement.
- Line clearance and control of powder processing/packing and filling area, to assure the packing attributes (e.g: contamination/weight/artwork/stencilling/labelling/palletization/shrink wrap etc) as per defined checklist.
- Part of Investigation team for customer complaints, failure of batches/OOS and return batches to get their final disposal action plan in their assigned plant.
- Preparation of validation and equipment qualification protocol and reports as per defined VMP.
- Handling of change control to avoid any unauthorized changes in process/products and their tracking to ensure how much changes proposed and done with process, product, facility, equipment, and systems in their assigned plant/area.
- To ensure dispatches of consignment is being done as per finished goods released checklist/line clearance.
- Ensure proper sealing, labelling, weights verifications, palletization / shrink wrap of consignment to be done before dispatches of products.
- Ensuring FIFO and checking COA/other relevant documents for dispatched goods.
- Trending and tracking of rejected materials (RM/PM including inventory) in their assigned plant
- Always ensure availability of approved RM & PM at their assigned plant.
- Part of team for successful execution of external/internal audits (customer or regulatory/ISO) as per IMS, GMP/ICH standards, and accordingly responses to customer /agencies as CAPA against audit findings within stipulated timeframe. (IMS- ISO-9001:2015, ISO-14001:2015 & ISO-45001:2018)
- Responsible for monitoring of returns goods and their disposition in coordination.
- Understanding customer’s need and expectation from the products, designing, specifications as per standards and developing quality assurance process and method.
- Having good knowledge of evaluating process capability to ensure consistent quality of product.
- internal / external quality audits (such as IMS / customer) as per schedule.
- Tracking of CAPA (raised from customer complaints, customer audits, Internal audits, OOS, and plant round observations etc) and their closure action plan in co-ordination with operation at their assigned plant/area.
- Experiences of guidelines such as IMDG/ADR/IATA/CMV /GHS may have advantage to implement the product distribution in compliances way.
- Tracking of IMS audits (internal & external) finding Vs clauses and identify the improvement area across the crop manufacturing sites.
- Having experience to conduct training on QMS / IMS / GMP to manufacturing and quality team.
- Having experiences for RC logo audits/ RC-14001:2015
- Responsible for evaluation of supplier questionnaire and maintain record as per defined procedure.
- Responsible for preparation of audit planner and maintain record as pe defined procedure.
- **Essential skills**:

- In-depth understanding of QC and QA system inline with relevant regulatory / statutory standards.
- Working knowledge of data / statistical method analysis.

**Desirable**:Knowledge of following is desirable.

Requirement Good manufacturing (GMP). ISO-9001:2015, ISO-45001:2018, ISO-14001: 2015, ISO-17025:2017