Required Skills:
Asset Management, Benefits Management, Instrument Validation, Management System Development, Product Management, Requirements Management, Requirements Validation, Stakeholder Relationship Management, Strategic Planning, System Designs
Preferred Skills:
Secondary Language(s) :
Technical Product Management - Digital Quality Lab (DQL) Instrument Validation Specialist
The Opportunity:
- Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
- Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the worlds greatest health threats.
Our Technology Centres focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company s IT operating model, Tech Centres are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.
A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centres.
Role Overview:
Technical Product Management - Digital Quality Lab (DQL) Instrument Validation Specialist
Our Digital Quality Lab Instrument Material Management team operates as a technology product owner business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
The DQL Instrument Validation Specialist reports to the Laboratory Instruments Materials Management Product Owner. The DQL Instrument Validation Specialist will provide ongoing support to create sustain qualification packages for analytical and analytical ancillary test instruments/systems and the development and maintenance of future standards, within the digital validation system. The person will work within a cross-functional team to establish requirements, review designs, test and deploy solutions that connect instrumentation and drive value through compliance and business process efficiency.
What will you do in this role
- Collaborate with local and global business partners to understand current and desired business processes, requirements with corresponding business goals.
- Support project completion in-line with established timescales, through collaboration with teams and cross-functional stakeholders.
- Develop and maintain instrument/system specific global System Development Life Cycle (SDLC) qualification documentation for analytical and analytical ancillary instruments/systems, including but not limited to Requirements Specifications, Configuration Specifications and Test Protocols.
- Revise current instrument/system specific global SDLC qualification documentation in-line with Lab Transformation program, including instrument integration.
- Maintain SDLC documentation templates in-line with updates to QMS, ensuring harmonization across divisions.
- Maintain a list of compliant instrument/system standards for the network.
- Evaluate new instruments/systems for compliance to data integrity technical requirements and digital capabilities, ensuring software and hardware meet specifications, partnering closely with vendors and site representatives.
- Lead instrument/system demonstrations in partnership with vendors and site representatives from a business use and compliance perspective.
- Build and maintain strong relationships with vendors, clearly conveying our company expectations/requirements for compliant data management.
- Contribute to cross-functional team on lab instrumentation and digital workflows, supporting how systems integrate across infrastructure and networking layers
What should you have
- Degree in life science (e.g. Microbiology, Chemistry, Biochemistry), IT or engineering discipline.
- Strong background in pharmaceutical quality, laboratory or manufacturing operations.
- Minimum of 3 years of hands-on experience supporting robust testing strategies, execution, and review of SDLC deliverables for laboratory instrumentation systems.
- Broad understanding of computerized systems, IT, SDLC and corresponding business processes and qualification principles.
- In depth knowledge of Data Integrity regulations and requirements including FDA 21 CFR Part 11, EU Annex 11 knowledge and application.
- Demonstrates clear and professional communication skills in verbal, written, and visual formats, with the ability to explain technical concepts in a way that supports team understanding and collaboration.
However, we will be happy if you also have:
- Strong analytical, problem-solving and communication skills, written and verbal.
- Ability to work independently and as part of a team with a customer-focused mindset.
- Detail-oriented with a commitment to quality and compliance.
- Proven project management skills.
- Prior Experience with direct use of lab instrumentation and digital lab systems
- Experience using Digital Validation Systems e.g. Kneat eVal, X-Ray, TOSCA and Robot.
- Experience with instrument ontologies and FAIR Data
- Demonstrated interest in continuous improvement and digital transformation.
