GMP Compliant Manager
ProClinical is currently seeking a GMP Compliant Manager for a pharmaceutical company located in Somerville, MA. Successful candidate will be responsible for writing, investigating and managing the product complaints related to all activities associated with the complaint handling program at the company per corporate procedure and regulatory standards.
- Initiating, writing and managing the complaint investigation to completion.
- Serving as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes.
- Receiving, initiating, investigating, and concluding product complaint investigations using the current product complaints management software and coordinating all aspects of investigation through closure and/or providing oversight for complaint handling process.
- Applying departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
- Assessing product complaints and determining if escalation is required due to potential regulatory notification requirements.
- Interfacing and collaborating with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc. and the regional organization.
- Interfacing with external stakeholders such as CMO, Call Centers and vendors/contractors on product complaint issues.
- Assuring that all product complaints are investigated to the appropriate level within the required timeline.
- Critically reviewing and approving complaint investigations and sending customer response letter.
Skills and Requirements:
- BA/BS with 6-12+ years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing.
- Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
- Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
- Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
- Strong attention to detail, good organizational skills and well-structured.
- Skill in writing investigation summaries and complaint responses.
- Ability to work independently as well be an effective team member and leader.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sherron Howard at (+1) 267-435-8600 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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