Merck KGaA

Senior Specialist

Posted On

Jan. 28, 2025

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time or part-time possible

Apply By

Feb. 18, 2025

Job Description

Title: Specialist - Senior SpecialistLocation: Bangalore 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 InspectionsQualifications: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 automationExcellent project management and organizational skills.Strong analytical and problem-solving abilities.Effective communication and interpersonal skills.Exceptional communication and interpersonal skills.Ability to work independently and as part of a team.We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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