Jubilant Generics Ltd is hiring for the position of “Manager – Manufacturing Compliance” for its Roorkee plant.
About Jubilant Generics Ltd
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 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. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18.
Position Title: Manager – Manufacturing Compliance
Qualification: M.Pharma / M.Sc./ B.Pharma
Work Experience: 11-15 years of experience in Pharmaceutical Company
- Exposer to Regulatory guidelines and faced various regulatory Audits such as US-FDA, MHRA, TGA, ANVISA, PMDA, etc.
Work Location: Roorkee – Plant, Uttarakhand, India
Job Context: To review of Quality notifications like deviations and investigations for proper closure. Review of Non-Conformances, deviations, change controls, internal Audits, Annual product quality reviews and to perform an assessment on other impacting documents and related activities
Challenges: Meet timelines and be a part of the investigation team and lead the investigations of the manufacturing section for change control, Non-conformances, deviations, CAPA, Quality risk assessment, OOS, OOT, any other failures; and ensure the effective implementation of CAPAs.
- Handling and guiding production personnel in the closure of change controls and deviations.
- Follow-ups with respective departments for all the above notifications and ensure timely closure as per timelines.
- To ensure extension to various quality notifications are complying with requirements.
- Shall be responsible to participate in Quality Risk Management exercises whenever required and to facilitate the Quality Risk Management exercise.
- Self-inspection of production department and cross-functional departments. Review of Self-inspection notifications and ensure timely closure of action suggested.
- Assist in internal & external audits related activities.
- To perform gap analysis with respect to cGMP guidelines, current regulatory requirements & corporate policies/ SOPs, wherever required and to comply with the requirements and endorse the same.
- Ensures proper training is being done to all the personnel regarding the process, SOP’s, Compliance with CAPA.
- Ensure the technical writing in line with regulatory guidelines.
- Ensure the effectiveness of the CAPA
- Updating cGMP related practices and recent regulatory up-gradation to the personnel working on the shop floor to improve the systems.