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.
- Solid knowledge of risk management principles and data integrity requirements.
- Lead Auditor certification or equivalent audit leadership experience preferred.

📌 Senior Quality Specialist (Mumbai)
🏢 SoTalent
📍 Mumbai