PLG is currently seeking a highly motivated individual for the position of QA Specialist, who will be responsible for overseeing the quality control process, managing compliance, conducting risk assessments, and supporting continuous improvement initiatives within the manufacturing environment.

Group 10
Responsibilities:

  • Quality Control:
    • Monitor and oversee quality control procedures to ensure raw materials, intermediate, and finished products meet specified quality standards.
    • Collaborate with the Quality Control department to address any quality issues or deviations.
  • Regulatory Compliance:
    • Ensure that all manufacturing processes adhere to current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
    • Maintain up-to-date knowledge of regulatory changes and ensure the organization’s practices are aligned with these changes.
  • Documentation Management:
    • Manage and maintain comprehensive documentation for all quality assurance activities, including batch records, deviations, CAPA (Corrective and Preventive Actions), and change controls.
    • Review and approve Standard Operating Procedures (SOPs) related to quality assurance and manufacturing processes.
  • Risk Management:
    • Conduct regular risk assessments of manufacturing processes to identify potential quality issues.
    • Implement corrective actions to mitigate identified risks and ensure product integrity.
  • Training and Development:
    • Provide training and guidance to production and quality control staff on quality standards, regulatory requirements, and company procedures.
  • Audit and Inspection:
    • Coordinate and participate in internal and external audits and inspections.

Group 12
Experience:

  • Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related field.
  • 10+ years of experience in Quality Assurance within the pharmaceutical industry.
  • In-depth knowledge of cGMP, FDA/EMA regulations, and quality management systems.
  • Experience with regulatory audits and inspections.
  • Familiarity with electronic Quality Management Systems (eQMS).
  • Strong attention to detail and excellent problem-solving skills.
  • Effective communication skills, with the ability to train and influence others.
  • Certification in Quality Management (e.g., Six Sigma, ISO 9001) is a plus.

Senior QA Specialist 320

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