QEC Manager - Pharma (8-13 yrs)
To ensure regulatory compliance of IT and electronic systems for Global Piramal Pharma sites and corporate.
KEY STAKEHOLDERS: INTERNAL
- Business - Site / Corporate functions
- IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP Basis)
KEY STAKEHOLDERS: EXTERNAL
- IT Vendors
- IT Contractors/Consultants
Reporting to Senior Manager - QeC
- Graduate in Science/Pharmacy/Engineering
- Post Graduation - Science /MBA (Desirable)
- Candidate with 8-12 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity
- Work experience at pharmaceutical sites in the capacity of either QA, QC or CSV (preferable).
- To define validation strategy and review CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. for SAP, Trackwise, Argus, LMS, DMS etc.
- To have thorough understanding, practical approaches for Computer system validation (CSV) 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 ensure infrastructure ((Network, Servers, Cloud, Database) are qualified as per required Quality standards and required documents are in place.
- To review 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 perform periodic and audit trail review of computerized systems as per defined frequency.
- To support the initiatives undertaken by Quality eCompliance team across the Corporate/PEL sites.
- Perform IT Supplier assessment and ensure compliance of audit observations.
- To liaise with Site ITC 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.
- Ability to represent during regulatory audits and can able to perform Corporate & DI Audits of sites.
- To work along with CSV & Project Manager to ensure project timelines are met.
- Author, review and approval of SOPs, Guidelines/Policies as applicable.
- Guide and mentor site teams on compliance of IT and electronic systems.
SKILLS AND COMPETENCIES :
- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must)
- Good knowledge of CSV, GAMP 5 (Must)
- Good knowledge of Data Integrity requirements for Pharma (Must)
- Experience of working at Pharma Site - QC, QA, IT, CSV 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 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.) (Plus)