PHARMAFull-time
Quality Specialist (QMS, Documentation)
By Admin · Quality Assurance & Quality Control
BANGALORE (IN)ONSITEPOSTED: 9/5/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCKScience and Technology; Pharmaceuticals and Life Science
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
The Quality Assurance – Specialist is responsible for overseeing quality assurance processes within the Life Science division in India. The role is focused on ensuring products and processes meet required quality standards and comply with applicable regulatory requirements. The position combines Quality Management System ownership, audit and investigation activities, documentation management, quality metrics analysis, staff training, regulatory compliance, and continuous improvement.
Core Responsibilities
Develop, implement, and maintain the Quality Management System (QMS) in accordance with applicable regulatory requirements and industry standards.
Lead and manage quality assurance activities, including audits and investigations.
Collaborate with cross-functional teams to maintain product quality throughout the complete product lifecycle.
Monitor and analyze quality metrics to identify quality trends, potential issues, and improvement opportunities.
Prepare and review quality documentation, including Standard Operating Procedures (SOPs), validation protocols, and quality reports.
Provide training and guidance to staff on quality assurance practices and regulatory compliance requirements.
Drive continuous improvement initiatives aimed at enhancing product quality and operational efficiency.
QMS & Documentation
Maintain an effective quality management framework aligned with regulatory and industry expectations.
Support controlled quality documentation and ensure relevant documents are appropriately prepared and reviewed.
Work with SOPs, validation protocols, reports, and other quality-related records.
Ensure documentation supports consistent quality processes and regulatory compliance.
Audits, Investigations & Compliance
Lead and manage quality audits as part of the site's quality assurance activities.
Support and manage investigations associated with quality issues.
Ensure products and processes comply with applicable regulatory requirements and quality standards.
Apply knowledge of regulatory frameworks including FDA, EMA, NABL, and ANAB requirements.
Maintain alignment with relevant ISO and GMP quality standards.
Quality Metrics & Continuous Improvement
Monitor quality performance indicators and analyze trends.
Identify areas requiring corrective or preventive improvement.
Use analytical findings to improve quality processes and operational efficiency.
Drive continuous improvement initiatives within the quality organization.
Training & Cross-Functional Collaboration
Provide quality-assurance training and guidance to staff.
Promote understanding of regulatory compliance and quality practices across relevant teams.
Collaborate with cross-functional stakeholders in a fast-paced, team-oriented environment.
Support product quality across the product lifecycle through effective communication and coordination.
Education & Experience
Master's degree in Life Sciences, Chemistry, Engineering, or a related field.
7 to 9 years of experience.
Minimum 7 years of Quality Assurance experience within the pharmaceutical, chemical, life sciences, or biotechnology industry.
Strong understanding of regulatory requirements such as FDA, EMA, NABL, and ANAB.
Strong understanding of quality standards including ISO and GMP.
Professional Competencies
Excellent analytical skills.
Strong problem-solving capabilities.
Effective written and verbal communication.
Ability to work collaboratively with cross-functional teams.
Ability to operate effectively in a fast-paced, team-oriented environment.
Strong quality and compliance mindset.
Work Location & Employment
Location: Jigani, Bangalore, Karnataka, India.
Employment type: Full-time.
Company Culture & Development
Merck emphasizes curiosity, innovation, inclusion, belonging, and professional development. The company describes an environment where colleagues from diverse backgrounds contribute to excellence and innovation and where employees are provided access and opportunities to develop and grow at their own pace. The role contributes to the Life Science organization and its broader mission of advancing science and technology.
REQUIRED VERIFIED SKILLS
Master's degree in Life Sciences
Chemistry
Engineering or related field
Minimum 7 years Quality Assurance experience
Pharmaceutical industry experience
Chemical industry experience
Life Sciences industry experience
Biotechnology industry experience
Quality Management System
QMS
Quality Assurance
Audits
Investigations
Quality Metrics
SOPs
Validation Protocols
Quality Documentation
FDA requirements
EMA requirements
NABL requirements
ANAB requirements
ISO
GMP
Analytical skills
Problem solving
Communication
Regulatory compliance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
The job posting does not provide a specific salary range, bonus structure, or detailed monetary benefits. Therefore salary_min and salary_max are left blank rather than estimated. Compensation would generally depend on the candidate's 7–9 years of relevant Quality Assurance experience, advanced educational qualification, regulatory knowledge, QMS expertise, location, and internal job grade. The employer highlights opportunities for professional development, inclusion, belonging, and career growth, but no specific monetary benefits are stated in the supplied posting.
ORGANIZATION CONTEXT & CULTURE
Merck is actively hiring for this position.
INDUSTRY: Science and Technology; Pharmaceuticals and Life Science
EXPECTED CAREER ROADMAP
This Specialist role provides a strong pathway within Quality Assurance and Quality Management Systems in the pharmaceutical, chemical, biotechnology, and broader Life Science sectors. With demonstrated ownership of QMS, audits, investigations, regulatory compliance, documentation, quality metrics, and continuous improvement, professionals can progress toward Senior Quality Specialist, Quality Manager, QMS Manager, QA Manager, Quality Systems Lead, or broader site and regional Quality leadership positions. Experience across FDA, EMA, NABL, ANAB, ISO, and GMP frameworks can strengthen opportunities for regulatory-facing quality roles, supplier quality, compliance leadership, validation, quality systems, and global Life Science quality functions.
APPLICATION ADVISORY
Position your resume around 7–9 years of Quality Assurance experience and clearly demonstrate experience in pharmaceutical, chemical, biotechnology, or Life Science environments. Highlight hands-on QMS ownership, SOP development/review, validation documentation, audits, investigations, quality metrics, and continuous improvement. Explicitly list regulatory and standards knowledge such as FDA, EMA, NABL, ANAB, ISO, and GMP where genuinely applicable. Quantify achievements such as audit outcomes, investigation closure timelines, quality improvements, process-efficiency gains, documentation volumes, training delivered, or successful QMS implementations. For interviews, prepare practical examples involving audit findings, investigations, regulatory compliance, SOP changes, validation documentation, quality trends, root-cause/problem-solving, and cross-functional quality issues. Demonstrate both technical QA expertise and the ability to train and influence teams.
RECOMMENDED TRAINING
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