Manager / Sr. Manager - Quality Control

Zentiva

12 - 15 years

12 - 17 Lacs

ankleshwar

Posted:-1 days ago| Platform:

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Skills Required

industrial relations iso analytical pharma packaging instrumentation glp hse gmp ims

Work Mode

Work from Office

Job Type

Full Time

Job Description

Design & Implementation of cGLP for Pharmaceutical laboratory ensuring compliance with Global Quality guidelines, local FDA (Schedule M & L) and other regulatory requirements of importing countries and Zentiva Quality standard.
Ensure analytical method validation and transfer. Responsible for review and approval of SOPs, recording formats, test methods - specification, validation protocol / report, qualification and calibration of record of laboratory equipment, OOS/OOT/deviation investigation and re-analysis/fresh analysis decision, management of reference standards, Retained sample Management and training on GLP.
Ensure the maintenance of laboratory premises and equipment.
Manage Pharmaceutical laboratory activities by organizing / planning of sampling, testing, Qualification, Validation, Calibration, maintenance and related documentation.
Participate in failure investigation, to carry out root cause analysis of failure /market complaints if any. Maintain change control, deviation & CAPA system.
Responsible for reviewing the testing raw data, log book and related documents.

Testing

Organize and ensure timely sampling and testing of Chemical, Microbiological and Physical analysis of RM/PM, intermediates, finished goods and other samples for Pharmaceuticals. Also ensure timely analysis of stability samples, market complaints, process validation, cleaning validation and environmental monitoring samples.
Ensure the monitoring of the stability of the products & stability section.
Approval / Rejection of Raw Materials, Packaging Components and in process material.
Extend testing support for Microbial testing & stability sample management of API / PD products / intermediates.
Out Of Specification/ Out Of Trend Results investigations.
Organize trending of QC analytical data as a part of Statistical Quality Control.
To approve and monitor any contract laboratory.
Organizing calibration / maintenance / qualification of laboratory Equipment and laboratory area.
Organize collection and storage of Retention samples.

HSE / IMS / GMP / GLP

Implement the HSE and GMP norms, adherence to compliance, training and corrective actions in order to ensure that there is no deviation from the Zentiva standards and statutory HSE and GMP / GLP norms.
Implement the system of working established as per IMS / ISO requirements in the Quality Operations department.
Organizing and maintaining the health, safety and environmental management system.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
Reviewing pharmacopeias and change control evaluation

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