Quality Specialist (QMS, Documentation)

BANGALORE (IN)ONSITEPOSTED: 9/18/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCKScience and Technology; Pharmaceuticals and Life Science
Merck

ROLE OVERVIEW

Quality Assurance Specialist responsible for QMS management, audits, investigations, quality documentation, regulatory compliance, staff training, quality metrics, and continuous improvement within Merck's Life Science division in India.

ROLE DEFINITION & RESPONSIBILITIES

  • Develop, implement, and maintain the quality management system
  • lead quality assurance activities including audits and investigations
  • collaborate with cross-functional teams on product quality
  • monitor quality metrics and identify improvement trends
  • prepare and review SOPs, validation protocols, and reports
  • train and guide staff on QA and regulatory compliance
  • drive continuous improvement for product quality and operational efficiency
Reporting Hierarchy: Reports within the Life Science Quality Assurance organization and collaborates with cross-functional product, operations, regulatory, laboratory, and quality teams. Exact reporting line is not specified in the posting.

* 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
  • minimum 7 years of quality assurance experience in pharmaceutical, chemical, life sciences, or biotechnology industry
  • strong understanding of FDA, EMA, NABL, and ANAB requirements
  • knowledge of ISO and GMP quality standards
  • strong analytical, problem-solving, and communication skills

PREFERRED QUALIFICATIONS

  • Experience with QMS implementation, quality audits, investigations, SOP management, validation documentation, regulatory inspections, quality metrics, CAPA, deviation management, and continuous improvement

REQUIRED VERIFIED SKILLS

Quality assurance
QMS
GMP
ISO
FDA
EMA
NABL
ANAB
audits
investigations
SOPs
validation protocols
quality documentation
quality metrics
regulatory compliance
training
continuous improvement
analytical problem solving

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits may include professional development, learning opportunities, employee wellbeing programs, and standard corporate benefits; exact benefits vary by location and eligibility.
No salary or monetary bonus amount is disclosed in the supplied posting; compensation should be verified through the official application process.

ORGANIZATION CONTEXT & CULTURE

Merck is a global science and technology company operating across Healthcare, Life Science, and Electronics, with products and solutions serving customers, patients, and scientific communities worldwide.

TEAM SIZE: 60,000+ employees globally
INDUSTRY: Science and Technology; Pharmaceuticals and Life Science
Culture: Science-driven, collaborative, inclusive, curious, and innovation-oriented culture emphasizing quality, continuous development, belonging, and responsible progress in science and technology.

EXPECTED CAREER ROADMAP

Provides opportunities to deepen quality-system and regulatory expertise, with potential progression into Senior QA, Quality Systems, Quality Compliance, audit leadership, or broader Life Science quality management roles.

APPLICATION ADVISORY

Emphasize 7+ years of QA experience in pharma, chemical, life sciences, or biotechnology environments. Highlight QMS ownership, audits, investigations, SOPs, validation documentation, FDA/EMA/ISO/GMP knowledge, and measurable continuous-improvement outcomes.

READY TO SUBMIT?

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