Looking for Validation Test Engineers from Pharmaceutical Domain

Job Description

• We are hiring for a global manufacturer of integrated containment and delivery systems for injectable medicines delivering to worlds top pharmaceutical and biotechnology companies. IT People Corporation brings this opportunity to you to be a part of an innovative company operating across 5 continents and having 7500+ workforces across the world. About West Pharma: West Pharmaceutical Services Inc. Headquartered in Exton Pennsylvania USA West has more than 50 locations including 28 manufacturing facilities around the world: is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient West creates products that promote the efficiency reliability and safety of the worlds pharmaceutical drug supply. West is headquartered in Exton Pennsylvania and supports its customers from locations in North and South America Europe Asia and Australia. Wests 2016 sales of $1.5 billion reflect the daily use of approximately 112 million of its components and devices which are designed to improve the delivery of healthcare to patients around the world. You may also review West Pharma website (https://www.westpharma.com/) for more information about the organization. Job Title: Specialist D&T Validation and Testing Mode of Hire: 6 Months (Contract to Hire) Job Location: Bangalore (WFH) till the office is not gets ready in Bangalore . Job Summary: In this role you will ensure that all West Pharmaceutical Services IT systems satisfy current and future regulatory requirements of the FDA and other authorities. This includes but is not limited to GxP and 21 CFR Part 11. The Specialist Validation and Test Management creates and reviews compliance related documents and manages testing and develops and execute test scripts. This position is expected to function as a compliance and documentation and test lead. This role will make recommendations for improvements in processes and documentation practices as well testing processes and test automation. You will be looked to as the compliance and test expert and create manage and schedule working closely with the Product owner and subject matter experts to ensure quality in requirements and test execution as well all documents related to the project lifecycle. This role will lead the validation and test team in our Digital Technology Center and interacts closely with Quality Assurance department to ensure computer systems are compliant with regulations and internally approved processes. Essential Duties and Responsibilities: Leads the West Validation and Test team in the Digital Technology Center and is responsible for all compliance activities within assigned computer systems. The Sr. Specialist Validation and Test Management is responsible to ensure compliance to Wests Computer System Development Life Cycle (SDLC) and the respective quality and validation requirements including but not limited to: Product Lifecycle documentation Test Management Test Automation Quality Requirements Validation planning Test protocol generation execution and/or review Participating in system audits Participate in and/or lead teams to create review and manage documents as part of product developments Guide Digital and Technology team members on best practice regarding good documentation procedures related to cGMP and other regulatory requirements Responsible for the maintenance formatting and editing of D&T documents related to FDA cGMP compliance including but not limited to: Standard Operating Procedures Standard Operating Instructions Global Operating Procedures Specifications Qualification Documents Controlled Forms and other document types Other duties as assigned Knowledge Skills and Abilities: Proficient knowledge in GxP and GAMP5 Solid background / experience with enterprise Systems (i.e. SAP ERP) Self-motivated high work discipline pragmatic approach while able to enforce mandate excellent communication & people skills strong service and support orientation Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description Competencies/Authorities The Sr. Specialist Validation and Test Management provides guidance and direction to his team system owners and enforces adherence to Wests policies procedures and compliance plans. supports the global compliance and system validation framework with all its respective policies and procedures. acts as point of contact for audit relevant questions in regards of computer system validation. Escalates identified problems and risks to Director D&T Portfolio Mngt and CI Please refer to the Job description above

Job Summary