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Pharmaceutical Quality Assurance Specialist
3 months ago
We are seeking a skilled Quality Assurance Associate with a solid background in the Pharmaceutical Sector. This role involves critical responsibilities and offers long-term potential. Below is a detailed overview of the position.
Position Overview:
- Assess reported complaints with managerial support to classify defects and evaluate risks associated with marketed products.
- Lead investigations by collaborating with various departments (Production, Technical Services, Quality Control, etc.) to formulate a comprehensive investigational approach.
- Analyze Batch Production Records and conduct Root Cause Analysis during complaint investigations, utilizing process walks and analytical tools to uncover underlying issues.
- Inspect returned product samples and coordinate testing procedures.
- Ensure thorough retention examinations of products to facilitate investigations.
- Work alongside the Global Pharmacovigilance team to evaluate potential adverse events when necessary.
- Engage in Focus Factory Support teams for the planning and execution of investigations as needed.
- Oversee and coordinate sample shipments for testing, both internally and through external laboratories, adhering to necessary timelines.
- Collaborate with Quality Operations and production teams to devise effective corrective and preventive actions.
- Identify recurring defects and escalate issues for further action as required.
- Provide support for the preparation and submission of Biological Product Deviation Reports to regulatory bodies.
- Manage the complaint review process, ensuring timely closure of investigations.
- Document technical complaints and manage investigations in a prompt manner.
- Conduct manufacturing investigations and provide timely responses to Global Pharmacovigilance.
- This role requires working in an office and sample storage environment, demanding high levels of concentration and attention to detail.
- Proven ability to independently manage investigations in collaboration with relevant departments for timely complaint resolution.
- Experience in categorizing, planning, and approving Change Controls in partnership with responsible departments.
- Thorough understanding of compliance evaluations for master documents against established regulations and guidelines.
- Experience managing CAPA projects in collaboration with relevant departments to ensure timely completion.
- A minimum of a Bachelor’s degree in a scientific discipline such as Biology, Biochemistry, Microbiology, Immunology, Pharmacology, or Chemistry.
- At least 5 years of experience in the pharmaceutical industry with a focus on Quality Operations.
- Strong background in Good Manufacturing Practices (GMP) and experience interacting with regulatory agencies.
- Familiarity with various software applications, including SAP, Trackwise, and MS Office Suite.
- Strategic thinking and decision-making abilities in a fast-paced environment.
- Excellent verbal and written communication skills, with strong presentation capabilities.
- Proficient in technical report writing and able to work independently.
- Strong organizational, interpersonal, and teamwork skills.
- Effective problem-solving and analytical skills are essential for this role.
Pyramid Consulting, Inc. is a prominent player in the Pharmaceutical Sector, and we are actively seeking qualified candidates for this and similar roles.
