IT Quality Assurance - Life Sciences

Opening in Life Sciences IT Quality Assurance

Urgently looking for one of the top 3 MNC at Chennai & Mumbai location.

Skills Require: Life Sciences IT Quality Assurance

- Experience of 4 to 10 years with Life Sciences IT Quality Assurance

- Understanding of GxP and QA system background related to Computer Systems

- Excellent knowledge on the regional specific regulations such as USFDA, EMA, MHRA, TGA etc.,

- Exposure to ISPE’s GAMP 5 requirement

- Experienced in managing Software Development Lifecycle and Validation approaches from compliance and assurance perspective

- Exposure in assessing Risk based Computer System Validation and Electronic Records

Excellent working knowledge of

- GAMP 5

- USFDA Code of Federal regulations such as 21 CFR Part 11, 210, 211, 58, 820 etc.,

- ICH requirements

- Good Documentation Practices

- Good understanding of Application and Infrastructure Change Control Methodologies

If the JD matches with your profile, please revert with your updated resume @ jaya.verma@neerinfo.com

You can also suggest your friends or colleagues for the same.

Jaya Verma
Sr. HR Executive