Computer Systems Validation Lead(Pharma)

Country:

India

Location:

No. 683, Ground Floor,15th Cross, J P Nagar, Second Phase, Building before Indian Oil Bunk,Bangalore,Karnataka,560078

Role:  Computer Systems Validation Lead(Pharma)

Location: Bangalore, India

Full/ Part-time: Full time

Build a career with confidence

Carrier is the leading global provider of healthy, safe and sustainable building and cold chain solutions with a world-class, diverse workforce with business segments covering HVAC, refrigeration, and fire and security. We make modern life possible by delivering safer, smarter and more sustainable services that make a difference to people and our planet while revolutionizing industry trends. This is why we come to work every day. Join us and we can make a difference together.

About this role

As a Computer Systems Validation Lead, you will lead and manage the Validation Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering, and Professional Services teams in the requirements development and execution of validation projects to maintain regulatory compliance, meet industry’s best practices, and to align with business expectations.

Key Responsibilities:

• Define and maintain a global Computer System Validation (CSV) methodology and policies/procedures in accordance with current regulatory guidelines.

• Participate in sales and program design phase to identify customer validation requirements.

• Lead and manage all validation projects and activities for the development and release of products, in accordance with CSV and regulatory requirements.

• Review and approve CSV documents (e.g. validation plan/report, URS, FS, risk assessments, test protocols and test reports)

• Oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and user acceptance testing (UAT).

• Maintain and update validation documentation, ensuring its accuracy and completeness.

• Evaluate proposed changes to validated systems and recommend the level of validation support required.

• Lead internal audits of CSV activities, protocols and procedures.

• Identify, document, and track non-conformances and corrective/preventative actions related to validation activities.

• Pursue continuous improvement opportunities to ensure effectiveness of the validation program.

• Stay current on the latest GxP regulations and industry best practices for Computer System Validation.

• Conduct risk assessments to identify potential validation gaps. Propose and execute on mitigation strategies.

• Provide appropriate training and guidance to employees and partners on CSV procedures and policies.

• Identify, track, and provide response plans for key performance indicators.

Basic Qualifications

• Minimum of 5 years of experience in CSV-related field, with project management experience.

• 5+ years of experience managing cross functional projects

• Up to 5% Travel required

Preferred Qualifications

• Bachelor’s Degree in Quality or Engineering

• Experience with Medical Device Product Validation

• Experience and knowledge of ISO 9001 and ISO 17025 requirements

• Regulatory Knowledge: Comprehensive understanding of GMP, FDA, GAMP5 and other relevant regulatory guidelines

• Knowledge in the application of 21 CFR Part 11

• Knowledge of GxP regulations and their application to CSV

• Exceptionally strong written and verbal communication skills

• Ability to manage and prioritize multiple projects

• Experience with validation methodologies and tools

• Results driven by a strong customer and quality focus

• Ability to provide guidance and to execute in the development of validation documents and protocols

• Demonstrated ability to develop strong relationships and work with staff, colleagues, cross-functional teams, and third parties

Benefits

We are committed to offering competitive benefits programs for all of our employees, and enhancing our programs when necessary.

• Make yourself a priority with flexible schedules, parental leave

• Drive forward your career through professional development opportunities

• Achieve your personal goals with our Employee Assistance Programme

Our commitment to you

Our greatest assets are the expertise, creativity and passion of our employees. We strive to provide a great place to work that attracts, develops and retains the best talent, promotes employee engagement, fosters teamwork and ultimately drives innovation for the benefit of our customers. We strive to create an environment where you feel that you belong, with diversity and inclusion as the engine to growth and innovation. We develop and deploy best-in-class programs and practices, providing enriching career opportunities, listening to employee feedback and always challenging ourselves to do better. This is The Carrier Way.

Join us and make a difference.

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Carrier is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.

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