Senior Manager/AD - Validation Testing/Computer System Validation - Lifesciences Domain

Validation Testing/Computer System Validation(CSV) - Life Sciences Domain

Client : Top 3 IT MNC

Exp : 13-18 Years

Role : Sr Manager/Associate Director

Location : Chennai

Job Description:

- 13-17 yrs experience in Information Technology Life Sciences domain.

- Should have Worked in Various roles in Software Development, Testing, Verification and Validation(CSV), Quality Assurance, Project/Program/Portfolio Management

- Should have experience in process establishment, compliance and process improvement for IS0 13485 (Quality Management System for Medical Devices), ISO 14971 (Risk management standard for Medical Devices), CMMi, and TMMi certifications and external audits

- Worked in various Business domains - Drug Development Life Cycle, Laboratory Information Management Systems (LIMS), Chromatography and various Life Science COTS products Electronic Health Records

- Strong Leadership, interpersonal, communication, negotiation, influencing and problem solving skills. Very good at stakeholder management

- Experience in project/program management skills(PMP) and service management skills(ITIL)

- Knowledgeable and Experienced in FDA 21 CFR Part 11, GxP Regulations (GLP, GCP, GMP, GDP), HIPAA Compliance, and EDI Transactions. Good knowledge and experience in GxP regulated processes in the pharmaceutical industry

- Expertise in Interfacing with client management, project managers, project teams and project stakeholders

- Work Experience in Presales and business development team in preparation of solution approach, estimations, RFP response and Proposals.

- Excellent interpersonal, verbal and written communication skills

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