What are the responsibilities and job description for the QA Batch Record Reviewer position at Piper Companies?
Piper Companies is currently seeking a QA Batch Record Reviewer for our Audubon, PA location. The QA Batch Record Reviewer is primarily responsible for batch record review and ensuring that operations are conducted in accordance with current Good Manufacturing Practice.
Responsibilities include but are not limited to:
Required Experience / Education:
Responsibilities include but are not limited to:
- Review and approve Executed batch records. Support Product release, including review of validation reports and other supporting documentation to ensure that all information contained within, is correct and accurate
- Review and approve Master Batch Records and related Minor Document Change Requests. This will involve interaction with internal and external customers to achieve required timelines while maintaining product quality and compliance
- Actively support investigation of Batch related deviations and complaints. Ensure all internal and customer timelines are met.
- Liaison with clients to ensure quality expectations are met, including attending client meetings
- Assist in the compilation and review of APRs, and Risk Assessments
- Support and feed into the batch record KPIs and quality system metrics to identify trends and facilitate management review.
Required Experience / Education:
- HS Diploma
- 2 years relevant experience in a pharmaceutical quality assurance position
- Packaging or Manufacturing experience
- Knowledge of the basic GMP requirements of the pharmaceutical industry
- GMP document auditing/review
- Bachelors Degree
- Experience with the generation, execution and review of quality documents in a commercial pharmaceutical packaging facility, specifically batch record review
- Knowledge of the regulatory requirements and industry standards for pharmaceutical packaging processes