JOB OVERVIEW:

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 STRUCTURE:

Reporting to Senior Manager - QeC

QUALIFICATION:

- Graduate in Science/Pharmacy/Engineering

- Post Graduation - Science /MBA (Desirable)

EXPERIENCE:

- 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).

Key Roles/Responsibilities:

- 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)

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