Senior Associate, Quality Compliance Specialist
4 weeks ago
Job Summary:
As a Senior Associate, Quality Compliance, you will play a key role in ensuring the quality and compliance of our products. You will be responsible for reviewing and certifying batch records, packaging records, and QC lab records to ensure they meet regulatory requirements.
Responsibilities:
- Review and certify batch records, packaging records, and QC lab records to ensure compliance with regulatory requirements.
- Investigate site deviations, including planned and unplanned deviations, and ensure that conclusions and corrective actions are adequate.
- Review cleaning validation related documents, including plans, protocols, and reports.
- Support quality risk analysis related to manufacturing processes and equipment cleaning.
- Review periodic reports related to cleaning lifecycle, including Continued Process Verification (CPV) and Annual Cleaning Review.
- Ensure compliance with regulatory requirements on product, process, equipment, and release procedures.
- Assist in ensuring FDA Readiness Plan for the facility and provide support for all regulatory audits, internal/external inspections, and other audits.
Requirements:
- Minimum of 7 years of experience in the pharmaceutical industry.
- Experience working in an international multicultural matrix organization.
- Thorough understanding of GMPs, specifically those relating to good documentation practices.
- Ability to work effectively in an international multicultural matrix organization.
- Expertise in software applications such as MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, and LMS.
- Knowledge of project management principles, practices, techniques, and tools.
- Strong communication, interpersonal, and organizational skills.
Working Conditions:
Corporate Office Environment, Manufacturing/Production Environment, Laboratories, Warehouse Environment, Field Familiarity Environment.
Travel Estimate:
Up to 10%.
Education and Job Qualification:
Minimum of Bachelor's degree. Role supporting seminars and courses are an asset.
Language Proficiency:
Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
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