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Lead Quality Assurance Analyst
1 week ago
Overview
Germer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's established pharmaceutical operations. This role is pivotal in ensuring the quality and compliance of products, contributing significantly to the overall success of the organization.
Key Responsibilities
- Oversee the evaluation, endorsement, and final disposition of finished products, including the final Certificate of Analysis (CoA) signature.
- Manage client projects to guarantee timely and complete quality delivery.
- Facilitate the investigation and resolution of non-conformances, ensuring that appropriate corrective and preventive actions (CAPA) and change controls are implemented, with deviations properly addressed.
- Lead or engage in targeted cross-functional investigations and improvement initiatives.
- Timely review and approval of laboratory investigations, ensuring accurate identification of root causes.
- Support fellow QA associates and contribute to departmental training efforts.
- Assist QA management during regulatory inspections and audits.
- Examine Bills of Materials (BOMs), inspection protocols, pallet configurations, calibration documentation, and Standard Operating Procedures (SOPs).
- Conduct internal audits and aid in the preparation of audit reports.
- Maintain and update procedures related to quality assurance activities, supporting Annual Product Review (APR) reports by gathering batch record data and managing databases.
- Oversee the vendor complaint process effectively.
- Perform quality inspections on packaging lines as necessary.
- Support and maintain the site Document Control System.
- Review, approve, and finalize Document Change Requests.
Qualifications
- Bachelor's degree in a relevant scientific or technical field related to quality assurance.
- A minimum of 5 years of relevant experience.
- In-depth knowledge of pharmaceutical cGMP, industry standards, and regulatory requirements.
- Excellent verbal and written communication skills, with the ability to engage across various functions and levels of seniority.
- Proficient user of Quality management systems.
- Familiarity with Microsoft Outlook, Excel, and Word, along with other web-based applications.
- Comprehensive understanding of computer system validation and GAMP guidelines.
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