Job in Quality Assurance at Glenmark Pharmaceuticals

Job in Quality Assurance at Glenmark Pharmaceuticals
Glenmark Pharma Jobs - Careers at Glenmark Pharmaceuticals company, Grab this career opportunity to work in Glenmark Pharma. Glenmark Pharmaceuticals Ltd hiring for Freshers and Experienced Jobs candidates to work with the Company Glenmark Pharma posting new jobs Vacancy frequently as per availability of vacant post, Here you can check eligibility criteria and qualifications, experience required for the position, and jobseeker candidates can Apply Online or Offline or by scheduled walk-in interview for Current Glenmark Pharma Job Openings find more Pharma Jobs post.
glenmark pharmaceutical jobs,Pharma jobs,
About Glenmark Pharmaceuticals Ltd
Glenmark was founded with a vision to emerge as a leading integrated research-based, global pharmaceutical company. Our branded generics business has a significant presence in markets across emerging economies including India.
The generics business services the requirements of developed markets like US and Western Europe. Our API business sells products in over 65 countries including the US, various countries in the EU, South America and India.
With 14 manufacturing facilities and 4 R&D centers spanning across GPL and GLS, dedicated to the goal of enriching lives across the globe we believe that the real force behind our continued successes are dedicated employees from across 60 nationalities, committed to creating ‘A new way for a new world’.
Interested & eligible candidates need to apply online/offline via the given official website/address. You will get brief information on Glenmark Pharmaceuticals jobs openings like educational qualifications, selection process, eligibility criteria, and important dates given in the below article. So read this article till the end to get all the information regarding this recruitment. For more jobs visit

Glenmark Pharma Jobs Opening Details

Job in Quality Assurance at Glenmark Pharmaceuticals

Designation: Senior Manager (Data Reliability Officer)

Desired Experience And Knowledge
Educational Qualifications: M.Pharm / M.Sc
Experience: 14-16 years in Pharmaceutical Industry

Function: Quality Assurance

Job Location: Goa

Reporting to: Site Quality Head and Corporate Quality Assurance - Compliance Head

Role Overview / Purpose
To ensure laboratory controls and overall data reliability in the manufacturing site

Overall Job Responsibilities
  • Has overall knowledge of laboratory controls and manufacturing operations of drug product. Has experience of handling electronic data of manufacturing operation and laboratory system.
  • Implement and oversee systems and procedures to ensure complete, consistent and reliable data.
  • Review the data management process/procedures for both manual and electronic system including data recording, data review, data archival, electronic data management and ensure compliance to the relevant regulatory and industry guidelines e.g., but not limited to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance.
  • Review and approve the Quality Management system (QMS) events associated with data reliability and accuracy.
  • Ensure the accuracy and reliability of cGMP data and data supporting regulatory submission.
  • Conduct audits and gap assessments based on regulatory requirements and guidelines and implement CAPAS.
  • To review and ensure compliance to the procedures on SOP for 'Documentation and Review of Analytical Results', SOP for 'Review of Batch Production Records, SOP for 'Batch Release' and 'SOP for Review of Data Completeness and Reliability' during periodic audits.
  • Escalating gaps in cGMP data reliability to the site Quality Head and Corporate Quality Assurance Head, Compliance.
  • Escalation to Corporate steering committee, based on the nature of the gap observed and its impact on the data reported. Prepare monthly reports on data reliability status at the site.
  • Ensure initiation of CAPA at the site based upon action identified during Data Reliability review and its effectiveness check.
  • Include gap assessment and remediation plan, if any, for data reliability in the Quality Management Review at both site and corporate level.
  • Assess training program and conduct periodic training to employee from c GMP functions at the site on procedures related to data accuracy, completeness and reliability.

Key Relationships / Stakeholders
External: Regulatory Auditors

Internal (other than Direct Reports)
  • Head Site Investigation
  • Site Quality Head
  • Site Manufacturing Head Site Regulatory lead
  • CQA IT Systems
  • CQA Vice President Compliance

Knowledge and skills:

  • Effective communication (both written and verbally) and interpersonal skills.
  • Demonstrated "change agent" skills; inclusive of influence management, project management.
  • vision development, and people motivation skills. 
  • Demonstrated ability to identify and leverage internal and external opportunities.
  • Good experience as project lead or similar position

Knowledge on relevant Guidelines

USFDA inspection exposure

  • Experienced in Lab & Manufacturing Operation (OSD and SSD).
  • QMS.
  • Review of Electronic data, Regulatory requirements

Leadership/Managerial Attributes
  • Timely escalation to senior management
  • Decision making and Accountability
  • Ability to drive results with keen eye on accuracy and to work with strict deadlines
  • Ability to communicate at different levels in the organizational hierarchy Ability to work in a dynamic team environment
  • Other Requirements (License/Certification & Specialized Training)
  • Experience in Microbiology lab and Audit trail training will be an advantage.

Employment at Glenmark is based on merit, competence, performance, and business needs. Glenmark prohibits unlawful discrimination as mandated by applicable laws and extends to all its employees. Glenmark strictly prohibits retaliation against individuals who report harassment or discrimination, or who participate in investigations into such conduct
Selection Process
  • Based on Written / Personal Interview
How to Apply 
  • Interested candidates fulfilling the eligibility criteria can apply for this job.
Send CV To:

Important Links For

Post a Comment

* Please Don't Spam Here. All the Comments are Reviewed by Admin.
Post a Comment
To Top