JOB TITLE- Assistant Manager Quality Control, Pharmaceuticals
REQUIREMENTS
Education / Experience
Post Graduate in Science (Organic or Analytical Chemistry) or B.Pharm/M.Pharm
5-7 years in chemical & instrumental testing laboratory with exposure to GMP, GLP
Technical skills &
Competencies / Language
JOB PURPOSE
Generic
Implement quality control activities for Pharmaceuticals at Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements, living Group’s Values and Code of Ethics.
KEY ACCOUNTABILITIES
TestingPerforming and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals.
Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals.
Good Laboratory PracticePerforming and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.
Reviewing pharmacopeias for specification preparation.
Preparing SOPs, Formats, Specification, Analytical Test Record and other documents.
Managing reference standards, working standards, Laboratory chemicals & reagents.
Managing instrument laboratory with reference to spares, maintenance etc.
Managing Control Samples and related record.
Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device.
Investigating out of specification results, retesting and review the analysis records.
Maintaining & reviewing laboratory raw data and log book related to testing activity.
Responsible for reviewing the chromatographic data.
ValidationPreparing protocol and report for Analytical Method validation, cleaning validation and performing / organizing the validation exercise as per the protocol.
Support testing of process validation/verification samples
Management of laboratory ConsumablesIdentifying and planning requirement for laboratory consumables and monitoring the stock of chemical, glassware and printed material.
Co ordinationCoordinating with production, and warehouse for analytical activities.
OtherCompliance to HSE Requirements for QC operations
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
Train the subordinate for laboratory related jobs.
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
We are a team of more than 5,000 unique talents bonded together by our purpose to provide health and wellbeing for all generations. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
Data protection: It’s not just a checkbox – it’s our commitment! Please visit our Privacy Notice https://www.zentiva.com/gdpr/privacy-notice
