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Piramal Pharma

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3.9

based on 985 Reviews

Video summary

271 Piramal Pharma Jobs

Deputy Manager-QA

Piramal Pharma Limited

3.9

based on 985 Reviews

9-13 years

Medak

1 vacancy

Deputy Manager-QA

Piramal Pharma

posted 16hr ago

Job Role Insights

Flexible timing

Key skills for the job

Manual Testing Webmethods Compliance SCADA Risk Assessment GMP

+ 1 more

Job Description

Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.
Perform, review approve computerized system validation life cycle deliverables.
Responsible for implementation and compliance of data integrity at site as DICO (Data Integrity Compliance officer).
Implement regimen of Data integrity checks on shopfloor and updating of Data Integrity Risk Assessment (DIRA).
Responsible for handling and compliance of SOPs related to Data Integrity IT systems.
Review / conduct of investigations related to Data integrity, Computerized Systems, and engineering department as applicable.
Coordination for data integrity and IT-systems projects with stakeholders at site and corporate as well.
Handling Participation in internal Data Integrity audits, its compliance.
Involve in selection of Data Integrity (DI) champions Impart necessary trainings to the DI champions
Review of Change controls, Deviations, CAPA and other QMS tools.
Review of Periodic review reports.
Participated in supplier assessment for Computerized Systems, instruments equipments etc.
Review approve the schedules of data back-up restoration, time synchronization etc.
Audit trail reports review of computerized systems i.e. HMI, SCADA, DCS, etc.
Review and ensure the compliance of user management activities of Computerized Systems.
Preparation / review of the quality risk assessments i.e. part 11 compliance, data integrity etc.
Review the Qualification documents of the manufacturing equipments, facility, utilities and associated ancillary systems.
CAPA effectiveness verification.
GMP compliance verification for the manufacturing equipment area, utilities and testing instruments.
Review of software application qualifications.
Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.
Observe unsafe acts and conditions and take corrective preventive actions immediately, as necessary.
Report any incident/accident/near miss/illness to the superiors.
Follow companys quality procedures, standards, and specifications.
And any other job as may be assigned to you from time to time by HOD.
Also responsible for the work of the senior, in absence of senior.