QA Specialist

  • Cork
  • Permanent
  • JO-1710-62933_1508328007

Summary


QA Specialist


Essential Duties and Job Functions:

  • Prior experience in the Pharmaceutical Industry is required
  • QC background is essential, e.g. experience regarding equipment qualifications, analytical method transfers and technical issues within QC
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Participates in developing Standard Operating Procedures to ensure quality objectives are met.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
  • Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • May assist with compliance audits as required.
  • Interfaces with contract manufacturers to address documentation and compliance issues.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
  • Normally receives no instruction on routine work, general instructions on new assignments




Knowledge, Experience and Skills:

  • Demonstrate proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Proficiency in application of QA principles, concepts, industry practices, and standards.
  • Thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
  • Strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
  • Demonstrate audit and investigation skills, and report writing skills.
  • Strong verbal, technical writing and interpersonal skills.
  • Proficiency in Microsoft applications

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