Jubilant Generics Limited has announced a job opening for the position of Assistant Manager – Quality Assurance (QA). The job location is in Noida. Please refer to the following details to apply.
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organize our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.
Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively.
The manufacturing location at Mysore is spread over 69 acres and it’s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focuses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is the state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA. This business focuses on B2B model for the EU, Canada, and emerging markets.
Kindly refer to www.jubilantpharma.com for more information about the organization.
Title: Assistant Manager- QA BA/BE
Department: Quality Assurance (QA)
Qualification: M. Pharmacy
Experience: 8-10 years
Location: R&D Centre – III, Noida
Salary: Not Disclosed
- Responsible for understanding of regulatory guidelines, Standard Operating Procedures, and workflow.
- Responsible for review of Standard Operating Procedures of all departments
- Provide technical and regulatory expertise in the development and application of procedures, training materials, communications, and/or tools.
- Follow applicable Standard Operating Procedures for performing QA related tasks.
- Develop a checklist for conducting different audits to ensure compliance with Standard Operating Procedures.
- Assist departments in assessing vendors for key processes that are outsourced to third parties.
- Develop vendor audit plan and conduct vendor audits to ensure compliance with applicable regulatory guidelines and Standard Operating Procedures and Client’s Specific Requirements.
- Perform study-specific (in-process/retrospective) audits of bioanalytical data and ensure that audits are completed as per timelines for assigned projects and studies
- Prepare reports and communicate audit findings from audits to auditees.
- Follow up of all audit reports for completion of corrective actions and ensure timely closure of audit reports.
- Must have worked in a US-FDA environment.