Job
Description
Job Summary: The Manager - DT Validation Testing is a key role responsible for defining, maintaining and optimizing the Quality Management System (QMS) framework in the context of all DT 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 DT leadership to ensure DT 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 DT and accountable for ensuring computer system validation documentation for process regulatory compliance including GxP, EU Annex 11 21 CFR Part 11. Responsible to implement risk-based computer system validation methodology with emphasis on risk identification, assessment and mitigation controls. Guide DT 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. Education and Experience: Education: Requires Bachelor s degree in science related field, or Information Technology Experience: 8-12 years of experience in pharmaceutical validation of software applications, quality assurance, cGMP manufacturing. Preferred but not required: Agile Scrum Certification, ITIL 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. West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
