The Product Assurance Specialist, under the direction of the Manager will be responsible for the review of all executed Manufacturing Batch Record [MBR] documents in preparation for release. The Product Assurance Specialist shall also assist in the administration of the Deviation, Notice of Events, Non-Conforming Incidents and Laboratory Investigation Report systems.
- The Product Assurance Specialist is responsible for the review of all executed Manufacturing Batch Record documents to assure they adhere to current processes and procedures and that they are in compliance to cGMP requirements, CorePharma SOPs and those of the company’s customers, where applicable.
- Under the supervision of the Manager, prepares final review of Manufacturing Batch Record documents and enters final release status in SAP for all products deemed acceptable after review and ensures batch specific information is recorded in the Product Assurance database.
- Under the supervision of the Manager, reviews all requests for investigation tracking numbers for deviations [DRs], Notice of Events [NOEs], Non-Conforming Incidents [NCIs], and Laboratory Investigation Reports [LIRs] to assure accuracy, completeness and clarity. Will issue tracking numbers as applicable and be responsible for the filing of in-process and finished reports.
- The Product Assurance Specialist will assist in the preparation of tracking and trending reports for the investigation reports listed.
- The Product Assurance Specialist shall work through and with the personnel of other departments and functions to assure that documents are correct and available in a timely manner. This includes but is not limited to attendance at daily scheduling and planning meetings as appropriate.
- The Specialist will interface with planning, manufacturing, packaging, Quality Control, R&D, New Business Development and other groups/departments so as to assure that documents are available to support product release, new product introduction and/or other projects in accordance with pre-approved schedules.
- Investigation reports and/or other documents shall, as required by applicable contracts, be routed to Customer Quality Assurance for review and disposition. The incumbent shall establish and maintain systems and processes so as to assure that customer requirements for document review and/or approval are met.
- The Specialist will assist with the retrieval of files and preparation of information required for the assembly of reports for Annual Product Reviews to be submitted to Regulatory Compliance.
SCOPE OF RESPONSIBILITY:
- The incumbent is responsible for adhering to all written procedures and for assisting the Product Assurance Manager in verification of all executed Manufacturing Batch Manufacturing documents.
- Maintains the manual and electronic tracking systems for tracking product release, investigation and deviation reports
- Maintains all documentation systems and processes in conformity to cGMP requirements as well as internal requirements.
- Specialist may be called upon to perform other activities in support of the business at the direction of the Product Assurance Manager or Quality Operations leadership.
- Bachelor of Science degree. (Biology, chemistry, pharmacy) or equivalent years of relevant experience.
- Two  to five  years experience in a quality assurance function in the pharmaceutical industry.
- Strong communication skills (verbal/written) with a high degree of accuracy and an attention to detail are required.
- Proficiency in MS Word, Excel, PowerPoint is required. Skills in computer databases such as Access are a plus.
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