Roles & Responsibilities
- Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications.
- Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved
- Ensure validation strategies meet regulatory requirements and company standards
- Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved
- Stay updated on relevant changes to Amgen's SOPs and ensure validation practices are aligned with evolving standards.
- Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and data engineering teams to drive validation activities and meet project deadlines.
- Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan.
- Ensure timely and effective completion of all validation activities in line with project objectives and schedules.
- Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management.
- Identify opportunities for process improvements in validation activities.
- Stay current on new technologies , validation trends, and industry best practices to improve validation efficiencies.
- Collaborate and communicate effectively with the product teams.
Basic Qualifications and Experience
- Master's degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR
- Bachelor's degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR
- Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field
Functional Skills:
Must-Have Skills:
- 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.)
- Experience of working in software validation projects
- Strong experience on tools like ALM , JIRA etc
- Must have worked in Agile or SAFe projects
- Experience with automated and computer-controlled systems validation (21 CFR Part 11)
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation
- Candidate must be able to write validation scripts in ALM and execute them independently
- Experience with computer system validation and software validation is a plus
- Strong problem-solving and analytical skills
- Excellent communication and teamwork skills
Good-to-Have Skills:
- Understanding of compliance and regulatory considerations in master data.
- In depth knowledge of GDPR and HIPPA guidelines .
- Good to have prior work experience in MDM domain
- Hand son experience on JIRA, Confluence
- Professional Certifications
- CSV Certified
- Agile or safe certified
