Manager- CMO Job in Sun Pharmaceutical
- Sun Pharmaceutical
- 15 to 19 Yrs
- Other Maharashtra
- 2 months ago
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Job Description
- Title: Manager- CMO Date: Jan 10, 2025 Location: Sun House - Corporate Office Company: Sun Pharmaceutical Industries Ltd Position: Manager 2 - CMO Department: Corporate Quality Location: Mumbai/ Baroda Reporting Manager Title: DGM- CMO Job Summary: Accountable for quality oversight of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site & R&D) for US market. Essential Job Functions: Regular oversight visits of the CMO sites for review of process & practices and accordingly prepare visit reports. Coordinate with Sun site, commercial, corporate quality audit & the CMO site as SPOC for activities related to product manufacturing and release and other technical issues. To author and review quality agreements between Sun Pharma & CMO site. Also, ensure qualified and approved external service providers are used. To ensure presence and participation during manufacturing for process validation batches to ensure that the manufacturing process as per the approved BMR is followed. To witness testing of process validation batches including hold time studies and in-process testing are conducted as per the approved specification, test procedures & protocols. Review of quality system documents, facility & equipments, manufacturing & packing controls, labelling & laboratory controls at the CMO site at regular intervals. Cause based /routine visits to CMO sites (with reference to Market Complaints/Recalls/CAPA implementation and effectiveness check) Review of batch manufacturing & packaging records, analytical reports and COA/COC for batch release. And release of batches in SAP. Review of stability data, process validation report, analytical method validation report, specification/STP of FP, API COA, primary packing material COAs, approved vendor of RM/PM, APQR etc. To review quality system documents such as change controls, deviations, CAPA, OOS/OOT, product quality complaints, Recalls etc. Prepare & review SOPs as per Sun Pharma quality standards. Prepare approved vendor list for raw materials and primary packaging materials for the product to be manufactured at the CMO site. To prepare annual risk assessment of the CMO sites. Requirements and Qualifications: M.Sc./ B. Pharm / M. Pharm or equivalent. Industrial Experience & Knowledge: Total 15-18 years of experience in Quality Control, Quality Assurance, Quality and compliance, in sterile formulations manufacturing. Knowledge of GMPs in both domestic and international regulatory environments. In-depth knowledge of FDA guidances such as ICH is must. Strong organizational, interpersonal and communication skills. Ability to work effectively in multicultural matrix organization,
Employement Category:
Employement Type: Full timeIndustry: Medical / Healthcare
Role Category: Not Specified
Functional Area: Not Specified
Role/Responsibilies: Manager- CMO Job in Sun Pharmaceutical
Contact Details:
Company: Sun PharmaceuticalLocation(s): Other Maharashtra
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Keyskills: Quality Control Quality Assurance ICH Interpersonal Skills Communication Skills Quality Compliance
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Sun Pharmaceutical
From humble beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide. Our global presence is supported by...
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