Laboratory Quality Assurance

20 hours ago

Ahmedabad, Gujarat, India fe05d514-8c15-4270-ab77-3b33ea19a52e Full time ₹ 30,000 - ₹ 80,000 per year

Key Responsibility:

Analytical Data Review

  • Review and verify data from chemical and microbiological analysis for raw materials, in-process samples, finished products, and stability studies
  • Ensure data integrity and compliance with cGMP and regulatory standards
  • Approve Certificates of Analysis (CoA) for final product release

Quality Management System:

  • Conduct and review investigations related to laboratory incidents, out-of-specification (OOS), and out-of-trend (OOT) results
  • Identify root causes and recommend corrective and preventive actions (CAPAs)
  • Oversee the closure of laboratory deviations and ensure effective documentation

Trend Analysis and Reporting

  • Review and analyze quarterly trends for environmental monitoring (EM), personnel monitoring, and OOS results
  • Collaborate with microbiology and analytical teams to implement corrective measures based on trend analysis

Method Transfer and Validation:

  • Oversee method transfer activities between manufacturing sites or contract laboratories.
  • Ensure analytical methods are validated and suitable for intended use.
  • Review and approve method validation reports.

Environmental and Personnel Monitoring Oversight:

  • Review and evaluate environmental and personnel monitoring data to ensure the sterility of manufacturing environments.
  • Implement corrective measures when trends indicate potential contamination risks.

Standard Operating Procedures (SOPs) and Protocol Review:

  • Review and approve laboratory SOPs to ensure compliance with regulatory guidelines and internal quality standards.
  • Evaluate and approve method validation protocols and reports for chemical and microbiological analysis.
  • Review stability study protocols and reports to ensure accurate design execution.

Stability Program Oversight:

  • Monitor the execution of stability studies and review stability data.
  • Ensure stability programs align with regulatory guidelines and product specifications.

Audit Preparation and Compliance:

  • Prepare the laboratory for internal and external audits (US FDA, state FDA, customer audit etc.).
  • Conduct pre-audit checks to assess laboratory readiness and compliance.
  • Address audit observations and ensure timely closure of identified gaps.
  • Support regulatory inspections by providing necessary documentation and explanations.

Training and Competency Assessment:

  • Develop and conduct training programs for laboratory personnel on SOPs, regulatory guidelines, and good laboratory practices (GLP).
  • Assess and monitor the competency of laboratory analysts.

Continuous Improvement Initiatives:

  • Lead initiatives to improve laboratory processes and enhance efficiency.
  • Participate in cross-functional teams to drive quality improvement projects.

Regulatory Compliance and Documentation:

  • Ensure laboratory operations comply with cGMP, US FDA and other regulatory requirements.
  • Maintain comprehensive and organized laboratory documentation, including laboratory notebooks, logbooks, and validation reports.

Mandatory Requirements:

  • Valid B1/B2 Visa for the USA.
  • Willingness to travel for work, including international travel to the USA and other regions as required.
  • Have to work as per US timings when working remotely.

Key Skills and Competencies:

  • In-depth knowledge of Quality Control in sterile injectable manufacturing processes.
  • Experience of laboratory oversight for chemical and microbiology.
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in QMS tools and software.

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