ANI Pharmaceuticals needs to ensure its manufacturing and packaging operations comply with Good Manufacturing Practices (GMP) and relevant regulations.
Requirements
- Must have experience in a GMP environment, academic or otherwise.
- Experience following laboratory procedures and systems in Pharma or similarly regulated environment.
- Computer skills
- Previous work in a regulated environment
- Knowledge of GMPs
Responsibilities
- Perform packaging line inspections/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
- Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging.
- Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
- Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
Other
- Bachelors degree is required.
- Ability to coordinate multiple tasks in a fast paced environment
- Ability to read and follow procedures
- Ability to work independently
- Attention to detail
