Job Description
This role involves providing quality oversight to drug substance and drug product manufacturing operations.
* Support technology transfer and commercial manufacturing operations by offering quality control services.
* Review SOPs, risk assessments, change controls, and other relevant documentation associated with DS/DP manufacturing operations.
* Contribute to microbiology projects, including microbial method validation, testing, environmental monitoring, organism identification, facility qualification, cleaning validation, and process validation.
* Collaborate with supervisors and team members to monitor method performance and implement improvements.
The ideal candidate should possess a comprehensive understanding of current Good Manufacturing Practices (GMP), knowledge of microbial testing and control, and exceptional interpersonal and written communication skills.
Key Responsibilities:
* Ensure adherence to GMP guidelines in all aspects of pharmaceutical manufacturing.
* Develop and maintain strong relationships with cross-functional teams to facilitate smooth operations.
* Participate in the development and implementation of quality control strategies to improve efficiency and productivity.
* Stay up-to-date with regulatory requirements and industry standards to ensure compliance.
Requirements:
* Thorough understanding of GMP principles and practices.
* Strong knowledge of microbial testing and control methods.
* Excellent interpersonal and written communication skills.
* Ability to work effectively in a team environment.
Benefits:
A rewarding career opportunity with opportunities for growth and professional development.