Senior Quality Compliance Specialist, MÜNCHEN

A Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Client: Direct Client

Job Title: Quality Compliance Specialist III

Location: Wayne, PA

Duration: 7 Months + (Possible Extension)

Job Summary:

The Product Surveillance Specialist is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for pipe-line products and to deliver appropriate support in-line products enable a sustainable existence on the market. Product Quality Surveillance Specialist works closely and collaboratively with the Product Quality Management Leads and across Technical Operations and other functions / stakeholders across the Business to execute product quality surveillance strategies including but not limited to Product Quality Complaint handling, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions in to the post marketing surveillance.

Post Marketing Product Quality Surveillance:

• Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to

• Effective global Product Quality Compliant Handling

• Effective global Product Annual / Periodic Product Quality Review

• Support the provision of metrics regarding key performance indicators of quality from Product

• Quality Surveillance System in support of Suppliers

• Active participation in team meetings, demonstrated ability to interact professionally and effectively with peers, management, and leadership both within and outside the department, within and outside the company, including regulatory agencies and business partners on a global basis.

• Must possess ability to work in a goal-oriented, time line driven, and dynamic work environment.

• Must be a well organized, self-motivated, and demonstrate an independent work style with the ability to initiate and follow through on goals and project schedules.

Specifically the Complaint Specialist shall:

• Process global commercial / clinical product Quality Complaints received

• Assess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations

• Liaise with International Quality to ensure intake of appropriately redacted international complaint data is received assessed and processed and potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriately

• Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions

• Perform trend analysis on all incoming PQCs escalating to incidents and potential risks to management

• Communicate adverse events reported in conjunction with PQCs to PVRM

• Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor)for inspection / investigation

• Coordinate pharmacy credits for returned product through Customer service

• Coordinate process and review PQC investigations performed at contract site manufacturer / packagers and site investigations in conjunction with Quality Assurance

• Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGMPs) in conjunction with technical and quality SMEs as appropriate

• Generate final correspondence summarizing investigational findings and communicate via letter or fax to complainant / or communicate via the relevant international QA to ensure local communication requirements are met.

• Generate reports for management and inspections as required

• Assist as needed in the preparation of data for internal audits and external audits / inspections

• Participate in third party call monitoring to ensure correct communication strategies are being utilized.

Transition/ Integration support:

• The candidate will additionally supported the transition and integration of legacy Product Quality Management quality systems for Complaints, Incident Management, APQR and Recall in to one solutions.

• Transition the ownership and processing of Complaints into PQM – execute a compliant transition, manage the SOP updates

• Support One Complaint system integration (One workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements)

Support as needed:

• One APQR system integration and enhacements (workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements). Support in the delivery of the new Canadian YBPR requirements

• Support the PQM Product Quality System alignment into single One Quality System

• Support change management of introduction of acquisition / integration / new products into and divestment of products out of the PQM Product Quality Systems

• Integration of One Recall and Withdrawal processes

• Integration of One Board of Health Notification processes

Qualifications

Education and Experience Requirements

• MS or Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing

• Previous experience investigating and processing Product Quality Complaints required.

• The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations.

• Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc.

Internal and External Contacts

• Internal contacts: PQM Leads, International Quality, North America Quality Assurance, Regulatory Compliance, Pharmaceutical Sciences, Global Pharmaceutical Technology, Global Regulatory Affairs.

• External contacts: Contract Organizations

Feel free to forward my email to your friends/colleagues who might be available

Additional Information

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter

Integrated Resources, Inc.

IT REHAB CLINICAL NURSING

Tel: (732) 429 1634 (Direct)

Ext: (732) 549 2030 x (212)

Fax: (732) 549 5549

http://www.irionline.com

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012, 2013 & 2014 (8th Year)

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