JOB TITLE: Manager Quality Control, Pharmaceuticals
REQUIREMENTS
Education / Experience
Technical skills &
Competencies / Language
JOB PURPOSE
Generic
Implement quality control activities for Pharmaceuticals at Ankleshwar adhering to regulatory / global quality guidelines 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 Ethics.
KEY ACCOUNTABILITIES
Testing and releasePlanning of timely sampling and analysis and review of raw material, bulk product, intermediates, finished goods, packing material and other samples for Pharmaceuticals.
Performing analysis of Raw Material Samples received from new vendors for Pharmaceuticals.
Planning For analysis of market complaints, Stability, process validation samples and Cleaning Validation of Pharmaceuticals.
Approval / Rejection of Raw Materials, Packaging Components and in process material.
OOS/OOT/Deviation investigations
Review of analytical, chromatographic and computerized data for intermediates, and APIs for Chemistry Ankleshwar.
Timely completion of calibration and calibration of laboratory instrument
Support troubleshooting of QC instruments
LIMS management and support to QC operations
Good Laboratory PracticePlanning for calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment.
Reviewing pharmacopeias for specification preparation.
Preparing SOPs and Formats and Analytical Test Record.
Managing reference standards, working standards, laboratory reagents & chemicals.
Reviewing and observing Retention Samples and maintaining record.
Investigating out of specification results, retesting and review the analysis records.
Maintaining & reviewing laboratory raw data related to testing activity.
Responsible for reviewing the chromatographic data.
ValidationPreparing protocol for Analytical Method validation/Transfer, cleaning validation and performing the validation exercise as per the protocol.
Management of laboratory ConsumablesIdentifying and planning requirement for laboratory consumables and monitoring the stock of chemical, glassware and printed material.
Co ordinationCoordinating with production, QA, QMS and warehouse for analytical activities.
OtherCompliance to HSE Requirements for QC laboratory.
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 team members for laboratory related jobs and evaluate for individual development.
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
