Posted:5 days ago|
Platform:
On-site
Full Time
The Senior Executive – Quality Assurance is responsible for ensuring effective implementation and maintenance of the organization’s quality management system (QMS) in compliance with applicable regulatory standards and company policies. The role involves proactive monitoring, documentation, auditing, and continuous improvement of all quality-related processes across departments.
Establish, implement, and maintain the Quality Management System (QMS) in accordance with ISO and regulatory requirements.
Ensure compliance with all applicable quality standards and internal policies.
Maintain and control all quality documentation and records related to the management system.
Review, amend, and update documents as required, ensuring proper retrieval and archival of obsolete versions.
Ensure timely issuance and archival of logbooks and other controlled documents.
Plan, schedule, and conduct internal quality audits as per the approved schedule to identify process or procedural deficiencies.
Participate in vendor audits and other external audits as required.
Assist in preparing Management Review Meeting (MRM) agendas, organizing meetings, recording minutes, and ensuring follow-up of action items.
Compile and review periodic quality reviews and annual document reviews.
Conduct periodic quality control checks to ensure compliance with established procedures and standards.
Prepare and execute annual plans for Inter-Laboratory Comparison (ILC) and Proficiency Testing (PT) programs.
Plan, coordinate, and follow up on the submission and review of reports related to Internal Quality Control (IQC), retests, repeat tests, and blind tests as per the scope.
Participate in identification, documentation, and investigation of Non-Conformances (NCs).
Initiate, monitor, and ensure timely closure of Corrective and Preventive Actions (CAPAs) in accordance with regulatory requirements.
Support continuous improvement initiatives across departments to enhance quality performance.
Review Standard Operating Procedures (SOPs) and ensure alignment with current regulatory and operational standards.
Provide training and guidance to staff on QMS procedures and quality practices.
Qualifications & Experience
B.Sc. / M.Sc. in Life Sciences, Biotechnology, Microbiology, Biochemistry, or Pharmacy.
Minimum 3–5 years of experience in Quality Assurance within research or testing environment (pharmaceutical, cosmetic, nutraceutical, or herbal sector preferred).
Sound understanding of ISO 9001:2015, GLP, AYUSH, and CPCSEA regulatory frameworks.
Preferred male candidates.
Core Competencies
Strong documentation and record management skills
Knowledge of audit procedures and compliance monitoring
Excellent communication, coordination, and follow-up skills
Analytical approach to problem-solving and quality improvement
Proficiency in MS Office and document control systems
Job Type: Full-time
Pay: From ₹29,000.00 per month
Benefits:
Work Location: In person
Radiant Research Services Pvt Ltd.
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