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Senior Specialist
Merck
posted 1hr ago
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Flexible timing
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Job Description
- Title: Specialist - Senior SpecialistLocation: Bangalore 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:Bachelors 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
Employment Type: Full Time, Permanent
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What people at Merck are saying
Rating based on 2 Senior Specialist
reviews
Anonymous · Engineering - Software & QA
Likes
Work life balance and excellent culture Free Food and cabs Good benefits with competitive salary
- Salary - Good
+3 more
Dislikes
Still use old technology in some of the project
Senior Specialist salary at Merck
reported by
27
employees
with 5-12
years exp.
₹9.3
L/yr - ₹25.1
L/yr
15%
more
than the average Senior Specialist Salary in India
View more details
What Merck employees are saying about work life
based on 297 employees
Flexible timing
Monday to Friday
Within city
Day Shift
Merck Benefits
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