PHARMAFull-time
Quality Specialist (QMS, Documentation)
By Admin · Quality Assurance & Quality Control
BANGALORE (IN)ONSITEPOSTED: 10/4/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCKScience and Technology; Pharmaceuticals and Life Science
ROLE OVERVIEW
Quality Assurance Specialist responsible for maintaining the Quality Management System, leading quality activities, ensuring regulatory compliance, and strengthening product and process quality within Merck's Life Science division in India.
ROLE DEFINITION & RESPONSIBILITIES
- •Develop, implement, and maintain the Quality Management System in accordance with 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 product lifecycle
- •Monitor and analyze quality metrics to identify trends and improvement opportunities
- •Prepare and review SOPs, validation protocols, reports, and other quality documentation
- •Provide training and guidance on quality assurance practices and regulatory compliance
- •Drive continuous improvement initiatives to improve product quality and operational efficiency
Reporting Hierarchy: Works within the Life Science division's quality assurance organization; Collaborates with cross-functional teams responsible for product quality, regulatory compliance, operations, and lifecycle activities
* 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 within pharmaceutical, chemical, life sciences, or biotechnology industry
- Strong understanding of regulatory requirements including FDA, EMA, NABL, and ANAB
- Knowledge of quality standards including ISO and GMP
- Strong analytical and problem-solving skills
- Excellent communication and cross-functional collaboration skills
PREFERRED QUALIFICATIONS
- •Experience with QMS implementation and maintenance
- •Experience leading audits and investigations
- •Experience with SOPs and validation documentation
- •Continuous improvement experience within regulated life sciences environments
REQUIRED VERIFIED SKILLS
Quality Management System
QMS
quality assurance
audits
investigations
SOPs
validation protocols
quality documentation
FDA
EMA
NABL
ANAB
ISO
GMP
quality metrics
regulatory compliance
continuous improvement
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Benefits and development opportunities; inclusive workplace; opportunities for professional growth; access to a diverse global environment across Healthcare, Life Science, and Electronics
The source does not disclose a specific salary range, bonus, or equity amount. Compensation details should be confirmed through the official recruitment process.
ORGANIZATION CONTEXT & CULTURE
Merck is a global science and technology company operating across Healthcare, Life Science, and Electronics, with a mission-driven culture focused on innovation, scientific discovery, and human progress.
TEAM SIZE: Global organization; exact employee count not stated in the provided posting
INDUSTRY: Science and Technology; Pharmaceuticals and Life Science
Culture: Merck emphasizes curiosity, inclusion, belonging, innovation, collaboration, and opportunities for employees to develop and grow at their own pace.
EXPECTED CAREER ROADMAP
The role can progress toward Senior Quality Specialist, Quality Manager, Quality Systems leadership, site quality leadership, or broader quality and compliance management positions within the life sciences organization.
APPLICATION ADVISORY
Emphasize 7-9 years of QA experience in pharmaceutical, chemical, biotechnology, or life sciences environments; highlight QMS implementation and maintenance; demonstrate audit and investigation leadership; showcase SOP, validation, and quality documentation expertise; mention knowledge of FDA, EMA, NABL, ANAB, ISO, and GMP requirements; provide measurable examples of continuous improvement and quality-metric analysis.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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