Senior Quality Assurance Specialist

4 days ago

Allahabad, Uttar Pradesh, India beBeeQuality Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Description:

The ideal candidate for this role will be responsible for leading and implementing quality assurance initiatives to ensure compliance with regulatory requirements. The position involves developing, maintaining, and improving Quality audit systems, GMP quality systems, and Behavioural GMP aspects.

">Key Responsibilities:
  • Develop, implement, maintain, and improve Quality audit, maintain GMP quality systems and Behavioural GMP aspects
  • Coordinate and perform all vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories and any other outsourced activities, Internal Audits, compliance audits,
  • Responsible for coordination and finalization for Qualified Person audits and Regulatory Inspections.
  • Responsible for CAPA close out for all audits and inspections
  • Develop, maintain and improve a GMP compliant document control system.
  • Establish a robust Quality Management System (QMS) to manage and implement change management, Deviation management, Incidents, complaint handling and CAPA management.
  • Responsible for All GMP trainings and Quality training programme
  • Oversee investigations of all non-conformances (deviations, complaint etc.).
  • Responsible for handling Product Recall
  • Create and maintain system to implement requirements of ICH Q8 (QBD), ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
  • Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
  • Develop batch Release and Reject system to ensure quality product is released to the market.
  • Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies
Requirements:
  • Keen understanding of pharmaceutical regulations and guidelines.
  • Strong leadership and project management skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.
  • Good analytical and problem-solving skills.
  • Experience with quality management systems and auditing.
Benefits:

The successful candidate will have the opportunity to work in a dynamic and supportive environment, with a competitive salary and benefits package.

What We Offer:
  • A challenging and rewarding career opportunity.
  • Opportunities for professional growth and development.
  • A collaborative and supportive work environment.
  • A comprehensive benefits package.

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