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Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.
PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.
PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.
For more details, please visit https://www.piramalcriticalcare.com/global/
Job Title
Senior Manager - Quality eCompliance
Job Description
To ensure regulatory compliance of IT and electronic systems for Piramal critical care sites and corporate. Responsible to support in implementation of IT Automation for quality processes across the Piramal Critical care sites.
Business: Piramal Critical Care
Department: Quality eCompliance
Location: Kurla
Travel: Low
Job Overview
To ensure regulatory compliance of IT and electronic systems for Piramal critical care sites and corporate. Responsible to support in implementation of IT Automation for quality processes across the Piramal Critical care sites.
Key Stakeholders: Internal Site functions - Site / Central Partner functions (e.g. SAP / Infra / Quality IT / Allied / SAP etc.)
Key Stakeholders: External IT Vendors IT Contractors/Consultant
Reporting Structure - Reporting to - Associate General Manager
Qualification & Experience
- Graduate/Post-Graduate in Science/Pharmacy
- Candidate with 10-14 years of experience in Pharma/Life science domain Working on IT Compliance, CSV, Part 11/Annex 11, Data Integrity
- Work experience in Pharma or IT Sector will be desirable
Roles & Responsibilities
- To support the IT initiatives undertaken by IT/Quality eCompliance team across the Central/PPL sites.
- To support Central and Site IT teams in CSV and other IT compliance activities with respect to regulatory guidelines.
- To establish governance for PPL sites (India, UK and US) and conduct periodic meeting to review and improve the CSV and other IT compliance activities.
- To perform Central & DI Audits of sites and to provide support during regulatory audits.
- To define validation strategy and review CSV deliverables for IT projects.
- To ensure compliance of CSV documentation.
- To monitor third party resource engaged for site activities under shared services.
- To review QMS documents e.g. Change control/Deviation/Incidents-Discrepancy.
- To perform Root cause analysis and define CAPA based on QMS documents review.
- To perform periodic and audit trail review of computerized systems as per defined frequency.
- Perform IT Supplier assessment and ensure compliance of audit observations.
- To liaise with Site QeC SPOC's for CSV activities and IT Compliance initiatives.
- To guide and train IT & CSV teams (Corporate & Site) for CSV, Data Integrity and Regulatory Compliance activities.
- To work along with CSV & Project Manager to ensure project timelines are met.
- Author, review and approval of SOPs, Guidelines/Policies as applicable.
- To inform DI Champion/PPL Manager in case of data integrity breach/issue.
- Any other tasks as assigned by his/her reporting manager.
Competencies
- Good knowledge of IT compliance, 21 CFR Part 11 / Annexure 11 (Must)
- Good knowledge of CSV, CSA, GAMP 5 Guidelines (Must)
- Good knowledge of Data Integrity requirements for Pharma (Must)
- Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must)
- Good Verbal and Written communication skills (Must)
- Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Must)
- Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must)
- Experience of working with Global Pharma Cross functional Sites – QC, QA, Manufacturing, IT, SAP etc. (Plus)
- Experience of validation on automation/digitization projects (Plus)
- Aware of industry best practices and knowledge about Pharma 4.0 (Plus)
