We are seeking a dedicated Quality Data Reviewer to support our batch release and stability programs.
Key Responsibilities:
* Data Integrity Specialist - review laboratory data in a timely manner to ensure compliance with pharmacopoeial and regulatory requirements.
* Trend Analyst - verify results against trend limits and specifications; identify and escalate deviations or lab investigations.
* Process Improvement Specialist - conduct trending of data and track the frequency of Not Right First Time (NRFT) events.
* Team Lead - provide QC and management support, maintaining clear communication across Quality and Production teams.
* Documentation Coordinator - maintain, update, and issue control prints, methods, specifications, and SOPs in line with regulatory requirements.
* Training Facilitator - contribute to training of analysts in relevant techniques, SOPs, and updates.
Requirements:
* Minimum 3 years of QC or related experience in a regulated GMP environment.
* Software Expertise - empower software experience is essential – must be confident in using software for data review.
* High Attention to Detail - high attention to detail and ability to prioritize tasks to meet tight deadlines.
* Deviations Management Specialist - experience in identifying deviations and supporting lab investigations.
* Quality Systems Manager - proficiency in quality systems and good understanding of regulatory compliance.
* Communication Skills - strong communication and interpersonal skills.
* Collaborative Team Member - ability to work independently and as part of a collaborative team.