Glenmark Pharmaceuticals Limited Hiring 2022. Glenmark Pharmaceuticals Limited Notification full details below..Interested and eligible candidates can Apply Now.Glenmark Pharmaceuticals Limited [Glenmark] is an India-based growing pharmaceutical company headquartered at Mumbai [formerly, Bombay]. Incorporated in 1977, the Company is focused on the manufacture and marketing of formulation products and active pharmaceutical ingredients [API] in India as well as globally and enjoys a diversified and growing presence in regulated and developing international markets.
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.
