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quality assurance administrator

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Location:
High Wycombe, South East
Job type:
Temporary
Date Posted:
19 July 2019
reference number:
QA653

Do you have experience in the pharmaceutical sector? Do you want to work for a leading global pharmaceutical company where your career can really take off?

If you can answer "yes" to any of these questions, we may have just the job for you!

We are looking for experience and to be responsible for handling product quality complaints from patients and healthcare professionals. If you have experience in the quality assurance function in the pharmaceutical or medical device sectors, we want to hear from you.

Benefits:

* On-site car parking and cycle storage
* Subsidised on-site restaurant
* On-site gym
* Comprehensive training
* Discounted staff shop
* Annual bonus scheme
* Shuttle-bus service to and from High Wycombe railway station

Pay rate and hours:

* £12.00 - £13.00 PER HOUR
* Monday to Friday 09:00AM - 17:00PM

Responsibilities:

Product Quality Complaint (PQC) Management will take up about 75% of the role and will include:

* 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
* Liaising with Drug Safety/Medical Information/Customer Services 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
* 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, Consumer, Drug Safety and Customer Services departments
* Regular communication with the general public, healthcare professionals, wholesalers, manufactures and suppliers

Requirements:

* Experience in the pharmaceutical or medical devices sectors, ideally including time in a quality assurance function
* Computer literate with good Microsoft Office skills
* 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 prioritise workload
* Excellent interpersonal, collaboration and verbal/written communication skills, self-motivated, clear thinker and organised
* Ability to communicate with internal and external customers
* 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 outcome of reconciliations.
* Education to GCSE level in the UK although qualifications in pharmaceuticals or pharmacovigilance would be beneficial
* Previous experience in an administrative support role desired
* Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas
* Drug safety experience would be useful.
* Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
* Ability to follow procedural guidelines, working practices, etc.
* Quality orientation with attention to detail and accuracy
* Understanding of medical terminology and ability to summarize medical information

If you have a quality assurance, drug safety, pharmacovigilance or pharmaceutical background, and you're looking for rewarding career with a global leader, apply today!

This assignment is to cover a secondment and will continue to the end of the year when it will be reviewed and may be extended.