
AQA- Data Reviewer
6 days ago
We are seeking a meticulous AQA - Data Reviewer to conduct quality reviews of key pharmaceutical documents and ensure compliance with regulatory standards, including 21 CFR. The ideal candidate will collaborate with cross-functional teams to maintain document integrity and support continuous quality improvement.
Key Responsibilities:
- Conduct thorough quality reviews of documents such as CAPAs (Corrective and Preventive Actions), change controls, and ensure compliance with 21 CFR regulations.
- Ensure adherence to company policies and standard operating procedures through detailed document reviews.
- Develop and maintain a comprehensive understanding of pharmaceutical regulatory requirements.
- Provide constructive feedback on document quality and recommend improvements where necessary.
- Collaborate with cross-functional teams to resolve document control issues and maintain compliance.
Required Qualifications:
- Postgraduate degree (MS/M.Sc) in Chemistry or related Science discipline.
- 2-5 years of experience in Quality Assurance or Quality Review roles within the pharmaceutical industry.
- Strong knowledge of CAPA, Change Control processes, and 21 CFR compliance.
- Experience with document review and quality management systems.
- Attention to detail and ability to analyze complex documentation.
- Excellent communication and teamwork skills.
Preferred Skills:
- Familiarity with QA management systems and regulatory documentation.
- Proficiency in using electronic document management systems (EDMS).
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