Corporate Quality Assurance - Pharma

I would like to share an interesting opportunity with you for the position of "Manager/ Sr.Manager- Corporate Quality Assurance" with one of the largest pharmaceutical giant.

If personally not interested, please feel free to forward it your friends and colleagues who may be interested in the same.

Job Details and details on the client organization is provided in the mail below.

Job Description :-

Job Title: Manager/ Sr.Manager

Salary: Would be best in the industry.

Education: Minimum Masters Degree in Software Engineering or related scientific field with 10+ years of experience in dealing with Computer Systems Validation or SAP QM module and having background of Pharmaceutical GMPs.

Job Profile:

- Review of SAP Configuration for QM module and mapping of process to meet requirement; Review of Test Scenarios, Unit Testing, Integration Testing

- Provide functional expertise and value added support by reviewing the system audit trail of enterprise level computer system software.

- Assure compliance to CFR Part 11/ Annex 11 requirements.

- Provide support to corporate functions and/or sites for pre-inspection readiness, employee training related to CFR Part11/ Annex 11 requirements.

Position Responsibility: This position leads and directs one of the Corporate Quality Assurance sub teams responsible for performing Audit of SAP QM module processes, scenarios, etc.; Audit of GxP IT systems (including the Qualification documents) with respect to CFR Part 11/ Annex 11 requirements of all Enterprise level Computer Systems implemented.

Technical Competencies Required:

- Experience of working in a pharmaceutical GMP environment.

- Conversant with requirements of cGMP, Annex 11, GAMP, 21CFR Part 11 as practiced in the pharmaceutical industry.

- Knowledge of computer systems validation regulations and requirements.

- Knowledge of SAP QM module or IT systems workflow design, establishment of user requirements, development of use cases, and verification.

Client organization details :-

A leading Pharmaceutical giant

Interested candidates can send their resume on seniorjobs@icresset.com

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