Candidates should have exp with tablets and capsule formulations, clinical products stage I - III, working with contract manufacturing organizations, they are a virtual company so the candidate will give documentation feedback to external manufacturing organizations.
Job Description:
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices GLPs)
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Works with Research and Development during new product start-ups, and identifies checkpoints for new products and processes.
- Normally receives very little instruction on routine work, general instructions on new assignments.