Quality Assurance and Compliance Specialist

11 hours ago

Ujjain, Madhya Pradesh, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,20,00,000

Job Title: Quality Assurance and Compliance Specialist

">About the Role:

This is a key position in ensuring compliance with regulatory guidelines. The successful candidate will be responsible for reviewing and approving procedures, identifying gaps, and updating documents.

">Main Responsibilities:
  1. Ensure compliance with regulatory guidelines by reviewing and approving procedures, identifying gaps, and updating the documents.
  2. Investigate deviations, incidents, market complaints, OOS, and OOT in a timely manner.
  3. Develop second-line personnel through training, enabling them to evaluate and implement risk-based approaches in decision-making.
  4. Coordinate with functions like R&D, production, engineering, RA, purchase, compliance, marketing to establish a robust quality system.
  5. Ensure analytical technology transfer is well-planned and successful at the site.
  6. Conduct training for technical staff, promote a culture of quality and compliance, and adhere to training schedules.
  7. Host audits by customers and regulatory authorities, actively participating in technical discussions and implementing actions to improve customer satisfaction.
  8. Provide regulatory and customer audit responses in conjunction with corporate quality, tracking CAPAs for timely closures.
  9. Investigate quality issues, provide technical clarifications, and identify infrastructural requirements for improved efficiency and effectiveness.
  10. Derive mechanisms for measuring productivity and achieve organizational QA&QC goals.
  11. Respond to marketing requests, track and update quality notifications, and ensure product quality trends are prepared and reviewed on time.
  12. Respond to regulatory queries related to analytical validation, complete qualifications and validations as scheduled, and prepare annual product reviews.
  13. Participate in quality management reviews, steering and presenting level-3 reviews to top management.
Requirements:

The ideal candidate should have experience in Biotech/Pharmaceutical API industry, particularly Microbial Fermentation (Classical).

">We Offer:

An exciting opportunity to work in a dynamic environment and contribute to the success of our organization.

">How to Apply:

Please submit your application, including your resume and cover letter, to us.

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