Description
DESCRIPTIONThe Complaint/Adverse Event Coordinator will investigate international and domestic complaints/adverse events in accordance with cGMP requirements.
Responsibilities
- Generate appropriate reports.
- Perform QA investigations for clinical and non-clinical complaints/adverse events by reviewing batch records, examining retention samples, inspecting returned product, and obtaining laboratory analysis or forensic testing, as necessary.
- Prepare complaint reports and submit to Product Quality by assigned due dates.
- Review packaging, manufacturing, and shipping processes/records and request investigation reports when necessary.
- Interact with manufacturing/packaging areas (Pearl River, Montreal, or other applicable sites) on product investigations.
- Maintain investigation records by creating and maintaining a paper file system and entering data into the WATSIN/PCOM 3.0 database systems, as required. This includes lot identification, manufacturing/batch record review, retention examination, returned sample evaluation, correspondences, phone conversations, and investigation reports.
- Review and revise complaint/adverse event/departmental Standard Operating Procedures.
- Prepare complaint investigation section for annual product reviews.
- Assist in preparation of monthly reports when necessary and perform trend analysis and data searches, when necessary.
- Work closely with manufacturing/packaging operations, and forensic testing laboratories, as applicable, to provide Quality oversight and support to complaint investigations.
- Participate in meetings and project teams and assist in issue resolution.
Qualifications
- Pharmaceutical experience a must
- BS preferably in Pharmacy (BS in Chemistry or Biology acceptable) with 3 years of experience in complaint/adverse event investigations or MS with 2 years of Quality experience as listed above.
- Investigation background, complaints processing, and excellent writing skills preferred.
- Experience with WATSIN complaint database, in particular the use of trending and tracking tools.
- Experience in managing/coordinating the complaint process from receipt of complaint to completion.
- MS Word expertise.
SKILLS
Pharmaceutical experience, BS preferably in Pharmacy, Experience with WATSIN complaint database, MS Word
Synectics offers competitive salaries and a full suite of benefits. EOE.