Position: Manager (G10) Effective Date:
Department: Corporate Quality Location: Bengaluru,
Reporting Manager Title: GM - Corporate Quality
Classification: Manager - Corporate Quality (Gamma Irradiation)
Job Summary:
- Manager Corporate Quality - Individual Performer Role
- Responsible for oversight of Gamma Irradiation of Sun Pharma products at third party gamma irradiation sterilization.
Essential Job Functions:
- Should possess sound knowledge of pharmaceutical manufacturing process (Non-sterile & Sterile formulations) & quality assurance regulations and auditing technique.
- Responsible for the overall supervision of Gamma sterilization site (Third party) used for sterilization of drug product and other components, as required.
- To monitor receipt and dispatch of consignment of Sun Pharma at Gamma sterilization site.
- Review and monitoring of irradiation process of the batch and related documentation.
- Review and monitor of analytical data (Dosimeter Testing)
- Control and monitor quality systems which enable operations on site to occur in an efficient manner and in compliance with cGMPs.
- Follow-up for timely closure of QMS documents.
- Participating in the investigations for Deviations, OOS and Audit findings related to Sun Pharma product/s.
- Review of changes in gamma sterilization process / major modification at site and timely notification to the management.
- Supporting in external audits preparations and responding to audit findings of gamma serialization sites
- Should be able to travel to third party site/s.
- Basic computer skills (Microsoft word/ Excel/ Power point presentation) and ability to learn and become proficient with appropriate software.
- Should possess good verbal and written communication skills.
Basic Qualification: B. Pharm / MSc
Industrial Experience & Knowledge:
- Minimum work experience of 10-15 Years in formulation & quality systems management operations.
- Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, ANVISA, TGA, WHO, ISO etc.
- Knowledge of Track wise/LIMS/SAP is desirable.
- Ability to work effectively in multicultural matrix organization.
