Job in Quality Assurance at Glenmark Pharmaceuticals
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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 www.tyropharma.com.
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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:
Functional
- 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
Technical
- 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: omkar.parab@glenmarkpharma.com |
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