Glenmark Pharmaceuticals Ltd Job Vacancy for QC Department

Glenmark Pharmaceuticals Ltd Job Vacancy for QC Department 

Glenmark Pharmaceuticals Ltd Job Vacancy for QC Department

Vacancy details:

Post Name: Head – Quality Control

Qualification: M.Pharma in Any Specialization, MS/M.Sc(Science) in Any Specialization  

Experienced: 18 – 20 years

Salary: at par with the industries.

Job Description: Greeting from Glenmark Pharmaceuticals Limited !!!!

Important Details :

Post of date:22/09/2022

Location: Baddi

Selection Process: The selection will be on the basis of Interview.

Roles and Responsibilities

Over all responsible for the activities of Quality Control function (RM/PM/IP/FP/GLP Stability & Micro).

To follow cGMP practices and to ensure Data Integrity and Reliability is maintained throughout Lifecycle.

Spearhead internal, customer and regulatory audits from QC front and arrange compliance as per stipulated timeline.

Exposure of Regulatory audits which must include USFDA.

Responsible for compliance of technology transfer, new ANDA, Exhibit batch, validation and commercial batches.

Explain the Quality systems and records to the auditors and visitors.

Ensuring that effective systems are used for maintaining and calibrating instruments.

Review the method validation document and suitability checking of Monograph methods.

Operational Excellence:

To ensure timely analysis of Finished Product, stability samples, Raw Material, Packing Material and microbiology samples.

Review and represent the QRM and plant performance to higher management.

Review and approve the QMS events and actively participate in investigation of OOS, OOT, Incidents and market complaints.

Review the URS, installation, operational and performance Qualification documents of equipments used in Quality control laboratory.

Review OOS, OOT, Analytical Method Validations and Laboratory incidents.

Working Standards & Reference Standards management review.

Providing support to packaging development and approvals

Review of Stability study program, ensuring GLP system in place at laboratory.

Having good exposure to handle the deviation, Risk assessment and Change Control through trackwise software.

Ensuring that the documents being submitted to regulatory are correct and in line with the requirement.

Reviewing, responding and strategizing quality regulatory submissions to meet the requirement of the concerned authority in regulated markets

Desired Candidate Profile

Exposure on hosting FDA inspections and observation remediation

Update on current Regulatory requirements and GMP trends

Knowledge on current GMP and GLP for Pharmaceutical Manufacturing

Ability to troubleshoot laboratory related issues.

Quick Decision making through scientific rationale

Lead the change implementation

Robust investigation through deviation, OOS, OOT, Complaints

Good technical writing skills

Good knowledge on physical, chemical, microbiological methods and techniques

Good knowledge on Analytical Development and validation

Good knowledge on computerized system validation and review of audit trials

Good knowledge on Data Integrity and Reliability norms.

Result oriented, solution provider, approachable, transparent and respect timelines

Understanding the importance of urgent resolution of cases impacting the business of the company

Ability to build and maintain strong collaboration with internal and external stakeholders

Detail oriented

Excellent sense of evaluating criticality of scenarios presented related to deficiencies of medicinal products

Ability to handle crisis situation

This position is for pure Quality Control role. 

Kindly share only relevant QC background resumes on prachi.jain1@glenmarkpharma.com.