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Chennai, Tamil Nadu 600 006
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Job Details

**Primary function**

Supporting for Sterile injectable Growth (SIG) projects activities & Compendial Compliance from site Quality

**Primary responsibilities & Duties**

+ Shipments of samples, standards and impurities as per submissions and launch requirements by meeting country specific requirements.

+ Supporting for Submissions and Commercial launches in the SIG & New project from site Quality.

+ Preparation, review, revision and management of Quality Technical agreements of Site with all external customers and sister sites.

+ PEER review of dossiers for submissions and deficiency response support from Quality.

+ Quality Risk assessment documents preparation, review and management .

+ Co-ordination for Analytical method transfers and Equivalency testing's in various countries from site Quality as a part of submission and product launch.

+ Preparation and review of the method transfer and verification protocols, summary reports, review of analytical data and reports.

+ Providing technical (analytical and documentation) support for all regional Quality teams and external laboratories from site Quality.

+ Initiation and review of Exception reports change controls & CAPAs for SIG related and supporting for investigation and timely closing of the same from both site and region.

+ Supporting for monitoring the compendial compliance procedure in the site. **Secondary/ Other responsibilities & Duties**

+ Timely communication and support for all requests from global SIG team.

+ Regular meetings in the Site with CFTs and teleconferences with different region Quality teams to review the SIG activities and open actions from site Quality.

Any other activities assigned by the supervisor/head QMS

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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