Job Description Summary
• Performing identification of Pharmacopeial Updates and its review. Implementation of Pharmacopeial updates Globally through change management process.
• Performing activity related to revision of product specification and method.
• To support audit activity as per requirement. Incident & Change control review. CAPA implementation.
• Review and implementing the common procedures as per department requirement.
• Review of ISO Guideline update.
Job Description
Job Description: -
- Identification, review and Implementation of Pharmacopeial updates Globally.
- Performing activity related to revision of product specification and method through change management process.
- Impact assessment of change.
- Review of ISO Guideline update.
- To coordinate with all interdepartmental activities pertaining to the USP/NF or other Pharmacopeial (if any) and ISO Guidelines.
- Report works completion status to reporting manager.
- Co-ordinate with Reporting manager for status update to the management.
- Preparation of quality metrics, Risk Assessment related to Compendial Review Team
- To perform the activity through QMS system compliance.
- Preparation, Review and implementation of Common SOPs / Procedures / Policies.
Education & Experience: -
- M.Pharmacy/M.Sc
- Minimum 6 To 8 yrs experience as QC/QC reviewer/QA (GMP).
Top Skills
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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