Novartis Released Job Openings On 13-09-2021.Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Eligibility for the Associate Manager Audit Planning GCP/PVy as follows.
Novartis Recruiting Qualification within Pharmaceutical-/Chemical-/Biological area, with Quality Background within Pharmaceutical Industry with 05+ Years of Experience for Associate Manager Audit Planning GCP/PV Position.Complete Details for the Associate Manager Audit Planning GCP/PV as follows.
Important Details :
- Location :Hyderabad
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 13/09/2021
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- Responsible for planning and co-ordination of all GCP and PV internal and external Audits according to Unified Quality Audit Program (UQAP).
- Support the Head of GxP Audit Planning and Data Management to establish the GCP and PV sections of the annual UQAP based on needs and requests submitted by local and global groups. Evaluate the audits on a risk- based approach in compliance with the Novartis Quality Manual, Audit Manual and Quality Directives.
- Review of submitted studies for all Investigator sites and define numbers of placeholders related to study specific audits and ensure the selection of study related sites on a risk based approach and in a relevant time window based on duration and enrollment of studies and audit history.
- Ensure the update and maintaining of TAPAS Database Audit History Reports (Risk database for Investigator sites).
- Ensure the UQAP is change controlled and continuous update, documentation of postponed, cancelled and added audits is in place and mirrored in AQWA (global database for Auditing). The traceability and tracking of changes to the
- Audit Plan must be transparent and efficient.
- Create AQWA-A audit records for audits (other than Investigator site audits which are created by the Data manager) and attach approved Change Request forms if applicable. Update audit records with auditor names, dates and status in AQWA audit Database and on the tracker.
- Provide regular updates (monthly, quarterly, on request) of UQAP to the Head of GxP Audit Planning and Data Management, ensure full traceability of changes to the audit plan; track audit status (audits scheduled, executed, etc.) and provide adequate assessment of audit execution of the Audit Plan.
- Support monthly KPIs and periodic reports by providing relevant data for GCP and PV Audits. Provide support to Data Management to maintain Master data (sites, targets and audits) in AQWA up to date, review and approval of all updated or newly created sites and targets.