Quality Assurance Associate

Quality Assurance Associate

Pharmaceuticals

Remote working

Contract until December 2021 with the potential of extension

£20-25 per hour PAYE

Purpose:

To maintain high levels of customer care, to support the credo, compliance requirements and continual improvement of product quality by processing product quality complaints (PQCs), including Lack of Effect reports, as required for Marketing Authorisation Holders (MAH) and Quality policies and standards. To provide QA support to the QMS and other quality projects as required.

Key Responsibilities:

Responsibility for product quality complaint (PQCs) handling to ensure timely case processing and alignment with metrics targets:

• Report intake – QA phone handling and review Quality Assurance mailbox for incoming PQC reports, initial assessment to determine immediate action required and logging on Complaint management database, where required. 
• Liaising with Drug Safety/Medical Information/Customer Services where required to ensure full complaint information is received and documented.
• Review follow up information received from Drug Safety, assess and log new PQC, update existing record as necessary. Ensure relevant follow up information is added. 
• Preparation of reports from Complaint handling database as required.
• Ensuring PQC actions assigned to the LOC are completed in a timely manner to allow for a timely complaint closure.
• Requesting for complaint investigations from relevant departments (e.g. Regulatory) where the LOC is responsible for the PQC investigation.
• Contacting reporter for sample retrieval, performing sample evaluation and arranging for its shipment to site of manufacture. Coordination of collection of Controlled Drug (CD) samples from reporters using couriers, arranging of applications for Home Office import/export licences and tracking such applications to ensure timely provision of CD samples to sites of manufacture.
• Processing PQC response letters – responding to complaint reporters to standard complaints. Ensure copies are retained according to records management schedules.
• Performing weekly complaint reconciliation with Medical Information, Drug Safety and Customer Services departments.
• Attend product quality complaint training sessions where relevant and provide refresher training to applicable business groups. Liaise with Business Quality Specialist in preparation for monthly complaint review meetings.
• Act as SOP owner/reviewer for specific SOPs, 
• Participate actively in other QMS activities such as deviation and CAPA management, handling of reported temperature excursions, PQRs, and other related activities as required
• Support the execution of specific projects within QA

Key Compliance Responsibilities:

• Report adverse events in a timely way to Drug Safety according to current Adverse Event Reporting guidelines/SOP 
• Acts in accordance with the company’s HCC requirements when interacting with Healthcare Professionals. 
• Complies with designated SOPs for the role 

Technical Knowledge & Skills:

• Computer literate with good Microsoft Office skills
• Experience in using TrackWise or other electronic management systems desirable but not mandatory
• Ability to assess quality information, to extract relevant data, and to decide which elements need to be entered in the database
• Self-identify relevant information and actions and prioritize workload 
• Excellent interpersonal, collaboration and verbal/written communication skills, self-motivated, clear thinker and organized.
• Ability to communicate with internal and external customers
• Proficiency in global and local SOPs 
• Ability to identify ways of streamline processes and take initiative in suggesting new approaches in order to drive continuous improvement.
• Ability to work meeting close deadlines
• Main decision-making areas:

What needs to be reported and when

What to do if a report does not contain complete information

Complaints follow up actions

Actions as an outcome of reconciliations 

Experience:

• Experience working in Quality Assurance in a regulated industry
• Minimal experience in customer facing industry is desirable but not required