Senior Manager - CSV bei PCC-India-Information Technology

To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. 

•    Business – Site / Central Partner functions
•    IT Team (e.g.  SAP / Infra / Quality IT / Allied / SAP etc)
 

IT Vendors, IT Contractors/Consultants, Piramal CSV Partner
 

• Graduate in Science/Pharmacy/Engineering
• Post Graduation – MPharm/Science/MBA (Desirable)
• Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity
• Work experience in  Pharma or IT Sector will be desirable
   

•    Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance of enterprise level applications.
•    Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements.
•    To create end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc.
•    To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms.
•    To perform Root cause analysis and define CAPA based on QMS documents review.
•    To support Quality Automations  Initiatives across the Central Partner functions/PCC/PPL sites.
•    To liaise with Site IT , Business SPOC’s for CSV activities and IT Compliance initiatives.
•    To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV,  and CSV Regulatory Compliance activities.
•    To work along with Business, IT, QeC & Project Manager to ensure project timelines are met.
•    Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc.
•    Author, review and approval of SOPs, Guidelines/Policies as applicable.

•    Good knowledge of 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)
•    Experience of working with Global Pharma Cross functional Sites – QC, QA, Manufacturing, IT, SAP etc. (Plus)
•    Experience of validation on automation/digitization projects (Plus)
•    Good Verbal and Written communication skills (Must)
•    Aware of industry best practices and knowledge about Pharma 4.0 (Plus)
•    Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Plus)
•    Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) 
 

Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.

PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.

Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.

Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.