Sr.Executive - Quality Control

Job Description:

Job Summary: As a Senior Executive in the Quality Control department, the incumbent will play a key role in ensuring the quality and compliance of pharmaceutical products through effective management of laboratory activities. The position requires expertise in analytical techniques, team leadership, and adherence to regulatory standards.

Responsibilities:

1. Analytical Testing:

   • Oversee and perform analytical testing of raw materials, in-process samples, finished products, and stability samples using a variety of techniques, ensuring compliance with established protocols and pharmacopeial standards.
   • Troubleshoot and resolve any technical issues related to analytical testing methods.

2. Method Validation and Transfer:

   • Lead and participate in method validation and transfer activities for new and existing analytical methods.
   • Collaborate with Research and Development teams to ensure smooth transfer of methods from development to quality control.

3. Quality Compliance:

   • Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines.
   • Participate in internal and external audits, addressing and resolving any quality-related observations.

4. Team Leadership:

   • Supervise and mentor a team of quality control analysts, providing guidance on testing methodologies, instrument operation, and compliance matters.
   • Foster a culture of continuous improvement, training, and development within the Quality Control team.

5. Documentation and Record Keeping:

   • Maintain accurate and comprehensive documentation for all quality control activities, including testing procedures, equipment calibration records, and analytical results.
   • Ensure that all documentation meets regulatory standards and is readily available for audits.

6. Quality Investigations:

   • Conduct and lead investigations into out-of-specification results, deviations, and non-conformances.
   • Implement corrective and preventive actions to address identified quality issues.

Qualifications:

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field.
• years of experience in pharmaceutical quality control.
• Strong knowledge of analytical techniques, instrumentation, and method validation.

Skills:

• Excellent leadership and team management skills.
• Strong analytical and problem-solving abilities.
• Good understanding of regulatory requirements and quality standards.
• Effective communication and interpersonal skills.

1) Handling of Quality Management system like 00,S/OOT/Deviation/CAPA and change control.       

2)Review and Approval of Method transfer protocol/report, Instrument qualification, working standard report.

3) Review of Audit Trail of Quality Control instrument.4)Involved in trend preparation of OOS/OOT/Lab Event.