PHARMAFull-time
Quality Specialist (QMS, Documentation)
BANGALORE (IN)ONSITEPOSTED: 9/29/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCK KGAAPharmaceuticals and Life Sciences
ROLE OVERVIEW
Quality Assurance Specialist responsible for managing QMS, quality documentation, audits, investigations, compliance, and continuous improvement within Merck's Life Science division in India.
ROLE DEFINITION & RESPONSIBILITIES
- •Develop, implement, and maintain the quality management system (QMS)
- •Lead and manage quality assurance activities including audits and investigations
- •Collaborate with cross-functional teams to maintain product quality throughout the product lifecycle
- •Monitor and analyze quality metrics and identify improvement areas
- •Prepare and review SOPs, validation protocols, reports, and other quality documentation
- •Provide training and guidance on QA practices and regulatory compliance
- •Drive continuous improvement initiatives for product quality and operational efficiency
Reporting Hierarchy: Reports within the Quality Assurance function and collaborates with cross-functional teams involved in product quality and regulatory compliance
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Master's degree in Life Sciences, Chemistry, Engineering, or related field
- 7-9 years of experience in quality assurance
- Pharmaceutical, chemical, life sciences, or biotechnology industry experience
- Strong understanding of FDA, EMA, NABL, and ANAB regulatory requirements
- Knowledge of ISO and GMP quality standards
- Strong analytical, problem-solving, and communication skills
PREFERRED QUALIFICATIONS
- •Experience leading quality audits and investigations
- •Experience with QMS implementation and maintenance
- •Experience with validation documentation and continuous improvement programs
REQUIRED VERIFIED SKILLS
Quality Assurance
QMS
Quality Management Systems
GMP
ISO
FDA
EMA
NABL
ANAB
Audits
Investigations
SOP
Validation
Quality Metrics
Regulatory Compliance
Continuous Improvement
Analytical Skills
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Inclusion and belonging programs; learning and development opportunities; career growth support
No salary or variable compensation figures are disclosed in the job posting.
ORGANIZATION CONTEXT & CULTURE
Merck KGaA is a science and technology company operating across Healthcare, Life Science, and Electronics, with a focus on innovation and solutions that support customers, patients, and scientific progress.
TEAM SIZE: Large multinational organization
INDUSTRY: Pharmaceuticals and Life Sciences
Culture: Merck emphasizes curiosity, innovation, inclusion, belonging, collaboration, and opportunities for employees to develop and grow at their own pace.
EXPECTED CAREER ROADMAP
Opportunity to deepen expertise in QMS, audits, investigations, regulatory compliance, quality documentation, and continuous improvement, with potential progression into senior QA, quality management, or specialized compliance roles.
APPLICATION ADVISORY
Highlight QMS ownership, audit and investigation experience, regulatory knowledge, SOP/documentation expertise, and measurable quality improvement achievements. Emphasize experience in pharmaceutical, chemical, life sciences, or biotechnology environments.
RECOMMENDED TRAINING
1/5
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