Pharmaceutical Quality Assurance Specialist

3 days ago


Blue Bell, Pennsylvania, United States Network Partners Group Full time
Job Title: Junior Quality Consultant

We are seeking a detail-oriented and motivated Junior Quality Consultant to join our team at Network Partners Group. As a key member of our quality assurance team, you will play a crucial role in supporting the development, implementation, and maintenance of pharmaceutical quality systems.

Key Responsibilities:
  • MHRA Inspection Gap Remediation:
    • Assist in identifying and assessing gaps from MHRA inspections and audits.
    • Collaborate with cross-functional teams to develop corrective and preventive action (CAPA) plans.
    • Ensure timely closure of gaps by following up on action items and providing necessary documentation.
    • Monitor the effectiveness of implemented corrective measures.
  • Supplier Qualification:
    • Support the evaluation and qualification of suppliers to ensure compliance with Good Manufacturing Practice (GMP) and other regulatory standards.
    • Conduct supplier audits and assessments, including reviewing documentation such as supplier questionnaires, audit reports, and certificates of analysis (CoA).
    • Maintain supplier qualification records and ensure they are up to date and meet regulatory requirements.
    • Assist in managing supplier risk assessments and collaborate with teams to mitigate quality risks.
  • Quality System Management:
    • Support the implementation and maintenance of quality management systems (QMS) in line with industry regulations and standards.
    • Participate in the preparation and review of Standard Operating Procedures (SOPs), work instructions, and other quality documents.
    • Assist in the development of quality metrics and performance indicators to monitor compliance.
  • Clinical Quality Support:
    • Provide quality support for clinical operations, ensuring alignment with Good Clinical Practice (GCP) guidelines.
    • Collaborate with clinical teams to ensure documentation, processes, and procedures are in compliance with regulatory standards.
    • Participate in internal and external audits to assess compliance with GCP, GMP, and MHRA regulations.

Requirements:

  • 2-4 years of experience in pharmaceutical or clinical quality assurance, preferably within a GCP or GMP-regulated environment.
  • Experience with MHRA inspection gap remediation is highly desirable.
  • Proven experience in supplier qualification and management.
  • Bachelor's degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field.
  • Strong knowledge of MHRA, GMP, and GCP regulations.
  • Familiarity with quality management systems (QMS), CAPA processes, and supplier audits.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams.
  • High attention to detail and the ability to manage multiple tasks simultaneously.
  • Proficient in Microsoft Office Suite and quality management software.


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