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.
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