Merck BSc Life Science Specialist Job, Apply Online
Senior Specialist
Job Id: 283674
Location: Bangalore, Karnataka, India
Job Type: Full-time
Job Description:
We are seeking a highly skilled and motivated Validation and Qualification Owner to join our team. The successful candidate will be responsible for overseeing the validation and qualification processes for our R&D IT systems, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Develop and implement validation and qualification strategies for new and existing products and systems.
- Create and maintain validation and qualification documentation, including protocols, reports, and standard operating procedures (SOPs).
- Coordinate and execute validation and qualification activities, including equipment qualification, process validation, and software validation.
- Collaborate with cross-functional teams, including engineering, quality assurance, and manufacturing, to ensure validation and qualification requirements are met.
- Conduct risk assessments and develop mitigation plans to address potential validation and qualification issues.
- Stay current with industry trends, regulatory requirements, and best practices related to validation and qualification.
- Provide training and guidance to team members on validation and qualification processes and procedures.
- Contribute to audits and inspections.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 4 years of experience in validation and qualification within the Pharma sector.
- Strong knowledge of regulatory requirements and industry standards (e.g. GMP, GAMP, FDA 21 CFR Part 211).
- Proven experience in developing and executing testing plans and test automation.
- Excellent project management and organizational skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team.
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