Quality Assurance Specialist

2 weeks ago


Abu Dhabi, Abu Dhabi, United Arab Emirates Oscar Full time
About Oscar

Oscar is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Our Mission

We believe in creating high-performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job DescriptionQuality Assurance Specialist

The Quality Assurance Specialist is responsible for supporting the development and maintenance of the Pharmaceutical Quality System. This role will manage and oversee critical quality system elements pertaining to supplier management, product dispositions, deviations, change control, CAPA and support Quality Management Review.

Key Responsibilities
  • Support the day-to-day quality systems for all products
  • Provide Quality oversight of clinical, commercial, distribution, and drug safety/pharmacovigilance activities
  • Oversee Document Control, Deviations, CAPA, Change Control, Complaints, Training and Metrics
  • Partner with Supply Chain, Regulatory Affairs, Tech Services and Management to ensure compliance with policies, procedures, and industry regulations
  • Provide Contract Manufacturing Organization (CMO) Quality Oversight
  • Support the evaluation of product quality complaints, investigations and associated CAPA(s) for potential reportable events
  • Support third-party supplier/CMO investigations
  • Facilitate the Document Control System
  • Support the administration of eQMS system
  • Facilitate the third-party change control system
  • Support the development and Management of the training program
  • Organize and present metrics for management review meetings and Quality Council
  • Support internal and external audits as needed
  • Assist as needed in the drafting of Quality Agreements
  • Participate in internal and external meetings and site visits to ensure cGxP compliance
  • Build relationships with Quality partners at CMOs to resolve quality issues in a timely manner
  • Compile and provide documentation and responses to Regulatory and Compliance requests (GMP renewals, RA questions and submissions, observations, compliance gaps, audits)
  • Support the compilation of Annual Product Quality Reviews
  • Engage in activities to continuously assess and improve processes
  • Support the assessment, implementation, and management of Risk Management Program
  • Other duties as required or directed by QAManagement
  • Support the Supplier Qualification program including, but not limited to: maintaining the Approved Supplier List in state of compliance, schedule, assign and conducts external audits, including issuing of audit reports and conducting follow-ups as appropriate


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