Assistant Manager-Quality Assurance

Job Summary:

We are seeking a highly motivated and detail-oriented Quality Assurance Professional to join our laboratory team. This role is crucial in ensuring the continuous implementation, maintenance, and monitoring of our quality management system, adhering to national and international standards. The ideal candidate will play a pivotal role in upholding regulatory compliance, driving continuous improvement, and ensuring the integrity of all laboratory operations.

Key Responsibilities:

• Quality System Management:

• Actively participate in and support all quality assurance-related activities.
• Implement, maintain, and monitor the effectiveness of the Quality Management System (QMS) in compliance with ISO/IEC 17025:2017, NABL guidelines, FSSAI, EIC, APEDA, AYUSH, GLP, Commodity Boards (e.g., Tea Board), and other relevant regulatory body requirements.
• Ensure systematic control and management of all QMS documents and records, including preparation, review, issuance, revision, and updates.

• Training & Development:

• Identify, plan, and execute internal and external training programs for laboratory personnel.
• Review and compile comprehensive training records.

• Corrective & Preventive Actions (CAPA):

• Monitor the effective implementation and verification of corrective actions (CA) and preventive actions (PA).
• Systematically resolve complaints and non-conforming work, actively participating in complaint closure actions.

• Technical Review & Oversight:

• Review and maintain records for method development, validation, and verification.
• Review test reports, calibration, and validation certificates for accuracy and compliance.

• Vendor & Equipment Management:

• Perform qualification and ongoing evaluation of vendors providing products and services to the laboratory.
• Plan, conduct, and monitor equipment calibration, validation, intermediate checks, and maintenance activities.

• Quality Control & Proficiency Testing:

• Plan, conduct, and participate in inter-laboratory comparison (ILC), proficiency testing (PT), and internal quality check (IQC) programs, ensuring meticulous record maintenance.

• Audits & Compliance:

• Assist and actively participate in the execution of internal and external audits, as well as Management Review Meetings (MRM).
• Support the preparation for and participation in customer and regulatory audits, visits, and inspections, ensuring successful closure of any non-conformances raised.

• Customer & Information Management:

• Review, assess, and evaluate customer feedback to drive improvements.
• Assist in LIMS (Laboratory Information Management System) operation and ensure its compliant implementation.
• Circulate critical regulatory and laboratory information, circulars, notices, newsletters, and recent updates/guidelines to all relevant company personnel.

• Risk Management & Continuous Improvement:

• Identify, assess, and mitigate risks, while also developing and verifying the implementation of opportunities for system and process improvement.

• General Support:

• Perform other duties as assigned by the Lab Head or Management.

Qualifications:

• Education:

  Master's degree in Biotechnology/Microbiology/Food Technology/Chmeistry or a related discipline.

• Experience:

  3-6 of progressive experience in Quality Assurance within a NABL accredited.

• Technical Knowledge:

• In-depth understanding and practical experience with ISO/IEC 17025:2017.
• Familiarity with NABL guidelines, FSSAI, EIC, APEDA, AYUSH, GLP, and other relevant regulatory requirements (e.g., specific to food, pharma, tea, etc.).
• Proficiency in laboratory quality control principles, method validation, and equipment calibration.
• Experience with LIMS operations is highly desirable.

• Skills:

• Strong analytical and problem-solving skills.
• Excellent communication (written and verbal) and interpersonal skills.
• Ability to conduct effective training programs.
• Meticulous attention to detail and strong organizational skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and collaboratively within a team.