Senior Quality Specialist

Senior Specialist - R&D Quality

Location: Mumbai, Maharashtra, India (Fully Onsite)

Industry: Personal Care Product Manufacturing

Work Setting: Fully Onsite

Are you passionate about ensuring quality excellence, regulatory compliance, and continuous improvement in research and development environments We are seeking an experienced Senior Specialist – R&D Quality to provide strategic quality oversight across laboratory, analytical, microbiology, stability, and product development activities while driving a culture of compliance, operational excellence, and risk-based decision-making.

Key Responsibilities

Quality Management & Compliance

• Provide quality leadership and oversight across research, development, laboratory, and product lifecycle activities.
• Ensure compliance with Quality Management System (QMS) requirements, regulatory standards, data integrity principles, and internal quality processes.
• Partner with cross-functional stakeholders to strengthen quality culture and promote continuous improvement initiatives.
• Monitor evolving regulatory expectations and support implementation of compliance requirements across business functions.

Stability Program Quality Oversight

• Review and approve stability protocols, reports, closeout documentation, and related records.
• Ensure stability programs are conducted in accordance with quality standards, regulatory expectations, and scientific best practices.
• Support initiatives aimed at improving stability processes, compliance, and operational effectiveness.
• Provide quality guidance for product lifecycle management and ongoing product performance evaluation.

Investigations, CAPA & Risk Management

• Lead quality investigations, deviations, non-conformances, and quality event management activities.
• Facilitate root cause analysis, risk assessments, and effectiveness verification processes.
• Drive implementation and monitoring of corrective and preventive actions (CAPA).
• Ensure timely closure of investigations and maintain compliance with quality and regulatory requirements.
• Support proactive risk identification and mitigation strategies.

Analytical & Product Development Quality Support

• Review analytical methods, validation documentation, technical assessments, development protocols, study reports, and related scientific documentation.
• Ensure analytical and development activities are scientifically sound and compliant with applicable regulations.
• Provide quality support throughout product development, testing, validation, and commercialization activities.
• Partner with technical teams to maintain quality standards throughout the product lifecycle.

Laboratory Quality Oversight

• Provide quality oversight of laboratory operations, ensuring adherence to established procedures and quality standards.
• Review laboratory documentation, training records, and compliance activities.
• Support laboratory investigations and continuous improvement initiatives.
• Maintain inspection readiness through ongoing monitoring and quality assessments.

Operational Excellence & Compliance Monitoring

• Conduct compliance reviews, laboratory assessments, operational walkthroughs, and process evaluations.
• Monitor adherence to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and data integrity requirements.
• Identify compliance gaps and implement corrective measures.
• Promote a culture of quality, accountability, and operational excellence.

Supplier Quality Management

• Lead supplier qualification, monitoring, and audit programs.
• Conduct supplier and third-party audits to assess compliance with quality and regulatory requirements.
• Evaluate supplier performance and support ongoing quality improvement initiatives.
• Manage quality agreements and ensure effective supplier governance practices.
• Collaborate with cross-functional teams to maintain robust supplier risk management programs.

Audit & Inspection Readiness

• Serve as a key quality representative during internal audits, external assessments, and regulatory inspections.
• Support audit planning, preparation, responses, and follow-up activities.
• Coordinate corrective action implementation arising from audit observations.
• Ensure sustained inspection readiness across quality and development functions.

Documentation & Records Management

• Review, approve, and maintain controlled quality documents including SOPs, protocols, reports, forms, and work instructions.
• Ensure effective document lifecycle management and record retention practices.
• Maintain compliance with documentation standards and regulatory expectations.
• Support continuous improvement of documentation systems and processes.

Digital Quality & System Validation

• Support validation and lifecycle management of computerized quality and laboratory systems.
• Review system validation documentation, testing protocols, and implementation records.
• Assist with deployment and maintenance of digital quality management platforms and learning systems.
• Promote technology-enabled solutions that improve compliance, efficiency, and data integrity.

Required Qualifications

Education

• Master's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Life Sciences, or a related scientific discipline.

Experience

• Minimum 10 years of experience in Quality Assurance, R&D Quality, Laboratory Compliance, Analytical Sciences, or other regulated laboratory environments.
• Demonstrated experience managing quality systems within highly regulated industries.
• Proven experience supporting quality oversight throughout product development and laboratory operations.

Preferred Qualifications

• Strong expertise in Quality Management Systems (QMS), investigations, CAPA management, supplier quality, audit management, and regulatory compliance.
• Experience with computerized system validation and electronic quality management systems.
• Familiarity with digital quality platforms, document management systems, and learning management systems.
• Experience conducting supplier, contractor, and third-party quality audits.
• Experience supporting regulatory inspections and responding to audit observations.
• Strong knowledge of risk management principles and data integrity requirements.
• Lead Auditor certification or equivalent audit leadership experience preferred.