Manager, D&T, Validation

3 weeks ago

Bengaluru, India West Pharmaceutical Services Full time
Job Summary

:The

Manager – D&T Validation & Testing

is a key role responsible for defining, maintaining and optimizing the Quality Management System (QMS) framework in the context of all D&T Systems & Project execution. The role will lead a team focused on validation documentation, development and execution of protocols along with strategic planning for complaint computerized application operations in a regulated Pharmaceutical GMP environment. Key application areas include enterprise ERP (SAP), MES, Laboratory and Digital Applications. Collaborates with key stakeholders like Digital Quality Assurance & D&T leadership to ensure D&T Systems are compliant with regulatory requirements and internally approved processes like change control.Essential Duties and Responsibilities:• Manage and lead Computer Systems Validation team within D&T and accountable for ensuring computer system validation documentation for process & regulatory compliance including GxP & 21 CFR Part 11.• Responsible to implement risk-based computer system validation methodology with emphasis on risk identification, assessment and mitigation controls.• Guide D&T team members on best practice regarding good documentation procedures related to cGMP and other regulatory requirements.• Develop and maintain computer system validation plans, qualification test protocols, IQ/OQ protocols, traceability matrices, SOPs/SOIs, Controlled Forms and all other documents within the scope of System Development Life Cycle (SDLC).• Participate & Lead in project teams to create, review, and manage documents as part of the delivery of the project overseeing the execution of validation plans & validation documents.• Participate & lead system audits which impact cGMP operations.• Ensure CSV Training material stays current and training of employees, temps and consultant to ensure compliance with our internal process and external regulations.• Collaborate with Digital QA to ensure documentation requirements are effectively communicated, understood, and met, and that the governing procedures are followed.• Coaches, trains, develops, motivates, and evaluates Validation team members to enable their capabilities and accomplish the department’s priorities.• Attracts, develops, engages, and retains talented individuals to achieve current and future business goals.• Ensures team members have access to training, coaching, and mentoring to thrive in their respective roles and enhance professional development.

Basic Qualifications:• Education: Requires Bachelor’s degree in science related field, or Information Technology• Experience: 8-10 years of experience in pharmaceutical validation of software applications, quality assurance, cGMP manufacturing.Preferred Knowledge, Skills and Abilities:• Deep expertise, understanding and knowledge of Computer Systems Validation in a regulated GMP environment for process and software.• Strong experience in SAP ERP implementation, auditing & validation requirements along with working knowledge of digital applications, IoT etc.• Understanding of business processes, controls frameworks, compliance and regulations for cGMP.• Working knowledge of regulations for electronic systems validation and data integrity (eg 21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance)• Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment.• Working knowledge of different tool sets like HP ALM, JIRA, DevOps, MasterControl for validation purposes.• Able to be aware of all relevant SOPs as per company policy relative to the position as applicable.• Self-motivated, high work discipline, pragmatic approach while able to enforce mandate, excellent communication & people skills, strong service and support orientation.Physical and Travel Requirements:• 10-15% travel, including global travel.• Prefer to work 12:00 Noon – 9pm IST. Willingness to work outside of these hours as needed.

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