Biocon Limited
Designation : Assistant Manager
Function : QA
Functional Area : IT COMPLIANCE
Job Role Summary : Preparation and review of IT systems Qualification, Validation protocols, documents, periodic audit trail review of IT systems
Job Profile :
- To prepare and review User Requirement Specifications, vendor evaluation questionnaire & checklists related to GXP, ERES and Data Integrity.
- To prepare and review validation documents such as Validation Plan, Qualification Protocol, Qualification Reports, Validation Summary report and other deliverables / documents as defined in SOP or Validation Plan.
- To execute qualification test scripts as applicable
- To ensure requirements specified by the user (within project scope) are tested during the validation as per risk mitigation.
- To ensure that all personnel including vendor involved in the execution of qualification activities are adequately trained.
- To ensure the defects identified during validation / qualification activities are logged and handled as per respective SOPs.
- Review Hardware/Server Verification documents of Digitization projects and ensure those are installed as recommended by Vendor or as per system requirement.
- To support sites cross-functional teams across all applicable sites for implementation of computerized systems.
- Support system owner / System administrator in responding to Quality related queries from end users
- To provide support to sites during audits for Software(s) implemented as part of Digitization.
- To ensure that all documents created as part of CSV deliverables are securely stored physically and digitally under custody of CQA.
- Control on Issuance, archival, retrieval and retention of documents and forms pertaining to CSV deliverables of Digitization Project.
- To perform Audit trail and Periodic review of computerized systems as per respective SOPs
- Managing validation activities / project deliverables are in line with the project plan / schedule.
- Performs all activities in support of our Biocon values and demonstrates strong and visible support of the values.
- Support & perform all other administrative duties, as assigned
- Performs all work in accordance with all established regulatory, compliance, safety requirements, company policies and procedures.
- Timely completion of assigned trainings in SAP SF.
Job Requirements :
- Â 8 - 10 years in IT QA functions
- Qualification and Validation of IT systems, Audit trail review
Work / Job Experience : 8-10 Years
Type of Experience : IT Compliance, Qualification, Validation in Pharma
Academic Qualifications :
B.pharma
