Manager, D&T, Validation

4 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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