Pharmaceutical Quality Assurance Specialist
4 weeks ago
We are seeking a dedicated Quality Assurance Associate with a solid background in the Pharmaceutical Sector. This role offers a unique opportunity to contribute to quality assurance efforts within a dynamic environment. Below is an overview of the responsibilities associated with this position.
Key Responsibilities:
- Assess reported complaints in collaboration with management to classify defects and evaluate risks associated with marketed products.
- Oversee investigations by coordinating with various departments to formulate an effective investigational approach.
- Analyze Batch Production Records and conduct Root Cause Analysis during complaint investigations, utilizing process evaluations and analytical tools.
- Inspect returned product samples and facilitate necessary testing.
- Ensure thorough product retention examinations are conducted to support investigations.
- Work alongside the Global Pharmacovigilance team to assess potential adverse events as needed.
- Engage in Focus Factory Support teams for the planning and execution of investigations.
- Coordinate sample shipments for investigational testing, ensuring compliance with timelines.
- Develop corrective and preventive actions in partnership with Quality Operations and production teams.
- Identify recurring complaint issues and escalate them for further action.
- Assist in the preparation and submission of Biological Product Deviation Reports to regulatory bodies.
- Manage the complaint review process, ensuring timely closure of investigations.
- Log and investigate technical complaints and manufacturing issues promptly, providing responses to relevant departments.
- This position requires a focus on detail and the ability to work in an office/sample storage setting, necessitating high levels of concentration.
- Proven ability to independently manage investigations and collaborate with various departments for timely resolution.
- Experience in categorizing and approving Change Controls in partnership with responsible departments.
- Strong understanding of compliance standards for master documents, including Product Specifications and Standard Operating Procedures.
- Experience managing CAPA projects to ensure timely completion.
- A Bachelor’s degree in a relevant scientific field such as Biology, Biochemistry, Microbiology, Immunology, Pharmacology, or Chemistry.
- A minimum of 5 years of experience in the pharmaceutical industry with a focus on Quality Operations.
- In-depth knowledge of GMP regulations and experience interacting with regulatory agencies.
- Familiarity with software tools such as SAP, Trackwise, and MS Office Suite.
- Strategic thinking and decision-making capabilities in a fast-paced environment.
- Strong verbal and written communication skills, with the ability to present information effectively.
- Exceptional technical writing skills and the ability to work autonomously.
- Strong organizational, interpersonal, and teamwork skills.
- Analytical thinking and problem-solving abilities are essential for this role.
This opportunity is with a prominent Pharmaceutical Company looking to enhance its quality assurance team. We invite qualified candidates to consider this position.
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