Senior Manager - CSV

Role: Senior Manager - CSV

Location: Baska (near Vadodara)

Job Responsibilities

• Demonstrated working knowledge of validation principles and cGMPs, FDA, EMA, TGA, ICH and PICs regulatory requirements, compendia and guidelines such as ISPE, applicable to computerized and automated systems.
• Leads CSV commissioning & qualification activities to achieve defined scheduled production start dates.
• Advanced knowledge of discipline; able to discuss regulatory expectations for validation activities, program and documentation.
• Demonstrated ability to plan and organize validation activities among cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
• Capable of independently discussing computer systems validation philosophies
• Work with the sites and lead to identify regulatory risks and appropriate remediation.
• Work in cross-functional Site Projects teams for Lab and Manufacturing systems other validation projects to include reviews, risk analysis and other QA activities in support of systems Sites.
• Review validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory)      
• Assist the lead in developing strategies for procedures improvement which caters to the needs of the quality organization
• Execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMPs)
• Review and execute the validation lifecycle documentation
• Work with the lead to review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions
• Provide Quality review and assessment of associated change requests related to computer systems
• Provide progress updates of the assigned deliverables and escalate issues to the lead appropriately
• Participate in trainings and workshops for knowledge transfer and competence building

Qualifications and experience

Required:

• Bachelor’s degree (or equivalent)
• 10 to 15 + years of experience in Pharma industry with a focus on quality and regulatory compliance
• Experience in systems validation
• Depth on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Guideline Annex EU 11, PIC/S, Regulation 21 CFR Part 11,
• Clear understanding of principles, procedures and governance of validation activities.
• Excellent written and oral communication skills.
• Motivation and skills to work in a team-oriented environment and a desire to work in a company that places a high value on cooperation and group achievement

Preferred:

• Master’s Degree
• In-depth knowledge of pharma quality systems including Validation Strategy for Lab and manufacturing systems Understanding of risk management and its application in design and quality systems.