Assistant Manager / Sr. Executive / Executive - Quality Assurance
Cadila Healthcare Limited
2 - 7 yrs
Ankleshwar
Job Description
Candidate should be familiar with cGMP requirements/ Data Integrity / Quality Management System (QMS) / Engineering Activity / Technology transfer documentation/ Trending and APR/ shop floor Operation in API / Bulk Drug Manufacturing.
a) Data Integrity - Responsible for reviewing of HPLC and GC , QC SOP Compliances, Investigation activities, OOS , OOT and Data of quality control instruments.
b) Quality Management System - Handling change control, process validation, investigations of OOS, OOT, Deviations and of Market Complaint
c) Engineering Activity- Review of Equipment qualification documents, Water system, HVAC, Preventive maintenance and Calibrations.
d) Technology Transfer Documents - Review and issuance TTD to plant , review of master batch record also review of specification and STP of API, Intermediate, RM, In-process.
e) Trending and APR - Knowledge of Market complaint, Deviation, Incident, Change control for trending and evaluation for improvement in process and system.
Company Profile:
Cadila Healthcare Limited
Zydus Cadila is a fully integrated, global healthcare provider, with strengths all along the pharmaceutical value chain. With a core competence in the field of healthcare, Zydus Cadila provides total healthcare solutions ranging from formulations, active pharmaceutical ingredients and animal healthcare products to wellness products. From a turnover of Rs. 250 crores in 1995, the group posted revenues of over Rs. 8600 crores in FY15. The group had posted a turnover of Rs. 4600 crores in FY 11, making it a billion dollar company. Recently, the group launched Exemptia, the world's first biosimilar for Adalimumab, the largest selling therapy worldwide for inflammatory arthritis.
Zydus is also the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world's first drug to be approved for the treatment of diabetic dyslipidemia. The Zydus group was one amongst the top five companies worldwide at the FT ArcelorMittal Boldness in Business Awards 2014 in the Developing Markets category and was declared as the 'Emerging Company of the Year' by the Economic Times Awards for Corporate Excellence 2010. The group aims to be a leading global healthcare provider with a robust product pipeline and aspires to post revenues of Rs. 10000 crore by 2015-16 and be a research-based pharmaceutical company by 2020.
Zydus is also the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world's first drug to be approved for the treatment of diabetic dyslipidemia. The Zydus group was one amongst the top five companies worldwide at the FT ArcelorMittal Boldness in Business Awards 2014 in the Developing Markets category and was declared as the 'Emerging Company of the Year' by the Economic Times Awards for Corporate Excellence 2010. The group aims to be a leading global healthcare provider with a robust product pipeline and aspires to post revenues of Rs. 10000 crore by 2015-16 and be a research-based pharmaceutical company by 2020.
Posts
