IT Quality Role - Compliance - Pharma

DEPARTMENT: Quality eCompliance

LOCATION: Kurla, Mumbai

REPORTING STRUCTURE:

Reporting to Senior Manager - QeC

QUALIFICATION:

- Graduate in Science/Pharmacy/Engineering

- Post Graduation - Science /MBA (Desirable)

EXPERIENCE:

- Candidate with 8-15 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).

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)