Quality Control Validation Specialist
4 weeks ago
Specific Duties:
- Supports and leads the design, development, and qualification/validation of analytical methods intended to assess critical quality attributes of raw materials, drug substances, intermediates, and products.
- Ensure evaluation and testing of GBI products are performed in accordance with regulatory standards, and scientific best practices and are completed on schedule.
- Participate in developing and managing stability program.
- Responsible for generating/reviewing Stability Protocols per ICH guidelines and generating the Summary Reports
- Review, write and supervise the execution of the input and output reports and SOPs
- Ensure all the exception documents are closed on time.
- Ensure all analytical raw data are reviewed and finalized on time.
- Oversee /Mentor compliance specialist /Data reviewer to review the documents in compliance .
- Participates in client audits and in other regulatory inspections, and meetings as required.
- Monitor laboratory notebooks to ensure issuance, review, and archival are conducted in a timely manner in accordance with established standards.
Education: Bachelor in biological or biochemical sciences or related field.
Experience: Must have at least five years of direct work experience in FDA regulated environment.
Skills:
- The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
- Excellent written and verbal communication skills with the ability to effectively promote intra-and inter-departmental cooperation.
- Knowledge of GMP, ICH, and compendial requirements and their application.
- Strong attention to detail, observation, organizational, and leadership skills.
- Possess strong character with self-confidence and integrity.
- Time Management skills
- Conflict Resolution.
- Critical Thinking.
- Priority Management.
- Diversity Awareness.
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