Strides Shasun Limited, established in 1990, is a listed & professionally managed, fully integrated, global pharmaceutical company. With a business footprint across pharmaceuticals (differentiated and branded generics), development and manufacturing (of intermediates, APIs and formulations) Strides Shasun is a valued player which manufactures and markets innovative branded generics and novel therapeutics that respond to health care needs worldwide. Strides Shasun Limited has world-class manufacturing operations (15 plants) in India, UK, Italy and Africa locations (5 USFDA facilities), dedicated R&D facilities at Bangalore & Chennai with 400 scientists and a strong commercial footprint across 85 countries to market our branded and commodity generics. Global Strength of 5500 employees. With presence in 85 countries & revenue exceeding 4500 Cr., Strides Shasun is among Top 10 Pharma Companies. Led by the strong leadership team, the organization is recognized as a strong competitor at global level. With aggressive strategic business plans, we are set to multiply the volume of business over the next three years. Strides Shasun hires top talent & provides then with environment of growth & learning.
Job Title: Executive Quality Assurance – Strides Shasun API Ambernath Plant
No of Posts: 02
Salary: Rs. 3,00,000 – 6,00,000 P.A.
Job Description:
- Review Batch Manufacturing and Analysis records.
- Maintain qualifications records. Ensure proper label control. Lay down procedures for periodic calibrations of various instruments.
- Prepare Annual Product Review Report, OOS and Deviations trending.
- Take rounds in production, QC and stores department to ensure compliance.
- Good knowledge of Current Good Manufacturing practices, Good laboratory practices, Good Documentation practices and Quality Management Systems.
- Experience in handling software like track wise, SAP etc.
- Knowledge of QMS activities like Conducting Investigations, Change Controls, deviations and related documents.
- Awareness about Data integrity principles and Experience in handling Data Integrity related issues.
- Handling of Regulatory inspections & customer audits.
- Control of process validation and cleaning validation activities. Review validation protocols, reports.
- Knowledge of water system & computer system validation.
- Good Communication & Interpersonal Skills.
Qualifications:
Essential:
- UG – B.Sc – Chemistry, B.Pharma – Pharmacy
- PG – MS/M.Sc(Science) – Any Specialization, Chemistry, M.Pharma – Pharmacy
- Doctorate – Doctorate Not Required
Desirable:
Candidate should have experience in API Plant – Quality background and Good Communication Skills desired. 3 – 6 Years experience preferred
