Deputy Manager-QA

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Deputy Manager-QA

Job Description

Computer System Validation (CSV) Specialist- Responsible for validating computer systems to ensure they meet regulatory requirements and perform reliably. Works closely with IT and business teams to ensure compliance with standards like GxP, FDA 21 CFR Part 11

1.    Ensuring that computer system validation deliverables like GXP, Software categorization, software qualifications, configuration specification, Risk assessment, negative challenging tests, backup & restore procedure, validation summary report, requirement traceability matrix and 21 CFR part 11 requirements are available for all the GxP systems

2.    To revisit the site specific SOP’s related to IT and ITC periodically to in line with the corporate IT guidelines/current regulatory standards and to maintain the work practices is in line with the current SOP’s.

3.    Preparation and Execution of the IT Roadmap for the site.

4.    Facing Regulatory and customer audits and presenting the IT compliance status with the support from the respective SME.

5.    Evaluating, reviewing the IT observations, internally, or during the audits, and supporting the respective department in identifying effective CAPA.

6.    To perform IT supplier assessment for GAMP3, GAMP4 or GAMP5, software before procuring.

7.    Perform adequate investigation and providing the root cause for the deviations identified during the failures/Deviations of computerized systems.

8.    To ensure that all the computerized systems are meeting the 21 CFR part 11 and electronic signatures/records requirements.

9.    To review and approve of all the validation/qualification documents related to computerized systems and ensuring the documents are in compliance.

10. To ensure that all IT related Risk assessments are made and necessary Risk mitigations are executed

11. Providing the sufficient training to the site team and ensuring that all the IT team members are become experts in their job role.

12. Report any incident/accident/ near miss/ illness to the superiors

13. Identify unsafe conditions and unsafe acts and report to superiors.

Bachelor of Science (Information Technology)