QA Manager QMS 

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our pharmaceutical and healthcare client, whose purpose is to reimagine medicine to improve and extend people's lives. They use innovative science and technology to address some of society's most challenging healthcare issues. They discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Job Title: QA Manager QMS

Work Location: East Hanover, NJ 07936

Job Type: Contract

Duration: 5 Months

Work Type: On Site

Job Description:

The primary responsibility of the Quality Assurance Sr. Analyst is to manage the day-to-day processes related to the Complaint Management activities under NCQ Complaint North America Hub responsibility, identifying and reporting high profile complaint events.

• Responsible for handling technical market complaints and processing in e-QMS (initial assessment)

• Responsible for initiating escalation, if needed, and following-up with country quality responsible

• Responsible for assigning complaint to respective manufacturing site/ESO, and any follow-up with reporter/customer SPoC for stakeholders, e.g. investigation sites, NPS, MedInfo-Call Center

• Responsible for complaints QA closure in system (e-QMS)

• Responsible for preparing feedback letter when requested (CO US) and drafting feedback letter (CO Canada) and sharing with CO QA Canada

• Responsible for performing local reconciliations with stakeholders, e.g. NPS and MedInfo

• Additional responsibilities include and are not limited to training of employees, reporting of metrics and strategies that will continuously improve the processes and customer service/customer satisfaction levels and outline course of actions as a result

• Provides Annual Product Review complaint data as per the required schedule Actively supports internal/external audits Act as backup to Complaint Management Lead

• Associates should have experience in pharmaceuticals, preferably in Compliance area with some expertise in Customer and Health Authority interactions.

• Experience preferred 5+ years of related pharmaceutical experience, technical report writing experience Thorough knowledge of cGMP requirements Excellent oral and written communication skills required. Ability to work independently under general direction or as a team if necessary.

• Knowledge of Pharma industry & processes, Country Quality processes - Complaints Management) - Sense of customer service and process orientation; attention to detail; team player - Ability to analyze complex scenarios and data

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.