Jul 2010
Present
Documentation Team member / Assistant Manager
Cipla Pharmaceuticals Ltd.
Indore, IN
- Work as a Training Coordinator for Quality department and ensure training of team members.
- Creation of Class (Training) in Learning Management Software (LMS).
- Review of Specifications, Standard Testing procedures and Standard Operating Procedures.
- Review of Pharmacopoeial updation (USP, EP, BP and IP) and implementation.
- Review of LIMS master in LIMS software (VMware).
- Formal Investigation of Non-Conformance, out-of specification and out-of trend and documentation of investigation including CAPA (In Trackwise application).
- Review and Verification of compliance and CAPA.
- Periodic review of documents
- Preparation an review of first level quality documents like Site Master File, Policies and Validation Master Plan etc.
- Handling of Change Control and Deviations for the department.
- Successful implementation of various Software like Cipdox (Documentum), LMS, Image Scanner.
- Implementation of Standard Operating Procedures in the department.
- Coordinate with departments like QA, QC and RA for the data collection for the preparation of Specifications, Standard Testing procedures and Standard Operating Procedures.
- Regulatory Audit Preparation like USFDA, TGA, WHO etc.
- Collection of Data required for regulatory submission from different departments.
- Maintenance and handling records for log issuance for various departments.
- Track the change control which is pending for closure and close out within specified timeline.
- Managing of workload as per exigencies and work distribution.
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