Senior Manager

Purpose - To perform Computer System Validation activities for the projects.

Position/Job Title - Senior Manager

Department CQA – CSV

Reporting To - CSV Head

Location - Ambernath

Dosage Form - NA

Job Responsibilities -

Act as a CSV team for all validation projects for standalone, network instrument/Equipment's and enterprise application

Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met.

Coach the implementation teams in the proper execution of validation documents.

Evaluate proposed changes to validated computer systems and recommend level of validation activities required.

Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology

Develop / review CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, deliverables within the scope of the validation plan.

Develop / review test plans, test scripts and user acceptance tests and manage the execution of test plans

Execute or oversee the execution of validation plans and validation documents

Perform project management activities for CSV process within the scope of the projects.

Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.

Work closely with stakeholders to ensure appropriate validation of cGMP computer systems.

Conduct or facilitate CSV and 21 CFR Part 11 trainings

Ensuring that all appropriate quality procedures are in place to support computer system validation

Ensure that all computer system validation activities are carried out in accordance with approved procedure and protocols

Monitoring compliance in accordance with regulations and established standards

Approval of gap / risk assessment plan, assessment checklist, for GxP computerized system in accordance with regulatory guideline

Review of all validation documents for accuracy, consistency and completeness.

Co-ordinate with external vendors / service providers.

Managing multiple site teams.

Qualifications & Pre-Requisites - B.Sc., M.Sc., B. Pharm, Graduate in Computer Science

Additional notes Will have to handle any other responsibilities if allocated.

Having knowledge on Pharma process.

Should have implementation/qualification/Validation knowledge and experience on QC and Manufacturing – Instrument / Equipment's and enterprise applications.
Skills Required
quality procedures , Test Scripts, Test Plans, Computer System Validation, 21 Cfr Part 11, Enterprise Applications, Project Management