About Cipla
Cipla is an Indian MNC with pharma and biotechnological products having the head quarters in Mumbai started in the year 1935. This has market capitalization of $7 billion. Company has footprints in India, South Africa, North America, Europe, and Australia. The company having primary focus areas in diabetes, arthritis, weight control, depression, cardiovascular and respiratory with 7 brands in top 100.
The firm also have numerous FDA approved bulk facilities. It acquired south African company in 2013 and named as Cipla-Medpro. It has more than 10,000 colleagues and 7 million chemists. Cipla believes that it not only produces medicines but makes difference in patients’ lives. Received Thomson Reuters India innovation award in 2012.
The formulation pipeline has equipped with more than 250+ complex products and with state of art facility for the development of innovative technological products. Developing the products with upcoming technologies like QBD (Quality by design) principles enabling robust and reproducible products in the market. Cipla biotech, stempeutics (in the area of osteoarthritis) and CIPTec discovery engine are the new ventures of the company.
About the Job
Location : Maharashtra - Vikhroli
Department : Quality Assurance - Corporate
Experience required : Candidate need to have 10-15 years of experience with Quality assurance in Pharma.
Qualification : Science or Pharma Graduate/ Post graduate
Thorough knowledge in Solid orals, Medical devices, Liquid orals and Sterile, Topicals are preferred
Need to have good communication and cGMP knowledge
Roles and Responsibility
Able to Lead corporate audits as per the schedule for further identify potential improvements and to verify Cipla practices against current requirements/ expectations
Required to Ensure adequate and timely response to external audit observations at Drug product (DP) and API sites to avoid regulatory actions by identifying the gap in draft responses shared by sites and guiding them for providing the appropriate response
Effective submission of MHRA, UK interim update document to agency from Cipla locations as per agency and timely requirement by tracking interim updates at a corporate level, for risk based inspection planning
Handling the inspection readiness of sites by sharing previous audit details/ observations in lieu of regulatory of same agency/ auditor with site to minimize observations during audit
Timely handling and Scheduling the external audits in coordination with different stakeholders to ensure In-house sites are compliant to GMP requirements
Need to track closure of commitments/ Corrective actions and preventive actions (CAPAs) to external audits by extending systemic issues to other Cipla locations in order to avoid similar observations and to implement best practices
For Formulator - NDDS
Location : Mumbai
Experience : 2-3 years with masters in Pharma or technology (Pharmaceutics)
Role
Able to design the experiments and should knowledge in literature collection required
Able to perform the risk assessments and handling the statistical data.
Compile the data and help in developing the formulation of NDDS
Developing the proof of concept for the new products