Quality Control Validation Specialist

4 weeks ago


Plantation, United States Goodwin Biotechnology Inc Full time
Job DescriptionJob DescriptionDescription:

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.
Requirements:

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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