Manager, D&t, Validation

At West we re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century Our story began when Herman O West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2 Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily West s indelible mark on the healthcare industry has just begun A name started our story How will yours help write our future There s no better place to join an inclusive community of professionals with opportunities for lifelong learning growth and development Supported by benefit programs we empower the physical mental emotional and financial health of our team members and their families We believe in giving back to help those in need in the communities where we live and work And are equally committed to creating a healthier environment and planet through our sustainability efforts 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 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 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 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 If you have a special need that requires accommodation in order to apply to West please send an email to 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