Position Type: Full Time
Career Function: SUPERVISOR
About Sigachi
Sigachi is an industry leader in the manufacturing of Excipients for Pharma, Nutra and food industries. Sigachi was incorporated in the year 1989 and has rapidly established itself as one of the largest manufacturers of Microcrystalline Cellulose worldwide. With three Multilocational facilities in Telangana and Gujarat, Sigachi has ensured supply chain reliability for its customers spread across the Globe. Sigachi’ s facilities are EXCiPACT GMP, SGMP, HACCP, EDQM CEP and ISO 9001:2015 certified. Sigachi has established itself as a quality conscious and dependable supplier in India and across Asia, Australia, American Continent, Europe, and Middle East, delivering newer differentiated Products which addresses the unmet needs of the Market.
Sigachi is a value driven company and fosters employee creativity, expertise, skillsets & wellbeing to achieve motto of “Experience Excellence”.
About the Role:
1. Planning of Organizing Production Schedules. Ensure production output at every shift & aim to achieve Target, Quality & Yield.
2. Execute all Operations in production function are conducted according to GMP standards practiced at SIGACHI Industries Ltd as per requirement.
3. Follow all operations as per SOPs.
4. Supervise all Employees/Casual workers/Contract workers are following the SOPs. Work closely with Quality control department for continuous improvement, utilize the available resources effectively to maintain and control the in-process quality parameters.
5. Follow the quality policy and achieve quality objectives.
6. Coordinate with Engineering Department, and cross functional teams to produce quality product.
7. Arrange production staff to provide on Job training and ensure the training records are updated.
8. Report every deviation, investigate, and close as per the Quality Management System.
9. Notify the change controls, record, and submit to QA for approval prior to implementation.
10. Execute the batch production record, review, and submit to QA within the set timelines before release of the batch.
11. Coordinate with QA to investigate all non- conforming batches, identify root causes, and implement CAPA (Corrective and Preventive Actions) and close.
12. Maintain batch identification records and traceability system is in place.
13. Demonstrate Good Housekeeping Practices inside the production area.
14. Practice and ensure all production personnel practice primary and secondary Gowning in process area.
15. Responsible for equipment/instruments Calibrations and Preventive Maintenance as per matrix.
16. Co-ordinate with engineering department in preventive maintenance and minimize the breakdown time.
17. Responsible for thorough cleaning after campaign of product charge over.
Responsibilities:
1. Responsible for carrying out Production following cGMP guidelines.
2. Handle entire Production area from planning, execution and move the released batches to dispatch section.
3. Accountable for production, productivity, quality of the process & products.
4. Monitor, control, and correct all critical parameters at all stages of production. Ensure proper utilization of resources.
5. Monitoring of general hygiene of persons working in production block and cleanliness of the area.
6. Checking and monitoring of the manufacturing activities of batch preparation area.
7. To ensure that products are produced and stored as per the procedures along with documentation.
8. To prepare and review the instructions relating to production operation and ensure their strict implementation.
9. To assist in the investigation of batch failures, Preparation of risk assessment, market complaints and product recalls.
10. To ensure that the required initial and continuous training of the personnel concerned is carried out.
11. To ensure an accurate monthly planner for 3 shifts including workforce as per the market demands and necessary plans are available to related departments.
12. To have good knowledge of Colors and their cleaning procedures. Knowledge of Film coating process is added advantage.
Job Specification:
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Qualification – Preferably B.Sc, M.Sc. B.Pharm, M.Pharm or B Tech (Chemical)
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Experience – 8 - 10 Yrs. from Pharma Industry/ Excipient Manufacturing