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Quality & Compliance Associate - £25/£30 p/h - 6 months
Premium Job From Experis IT
Recruiter: Experis IT
Listed on: 15th May
Location: Hayes
Salary/Rate: £25 - £30
Type: Contract
Start Date: ASAP
Reference: BBBH103447_1557929093_expired
Contact Name: Jakub Rurkowski

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Quality & Compliance Associate - £25/£30 p/h - 6 months

Quality & Compliance Associate - £25/£30 p/h - 6 months

The work location is based in Stockley Park on 6-months contact duration

Pay rate is between £25 - £30 per hour.

Purpose

* To support the Affiliate Quality Management System (QMS)
* Lead the administration of the change control process, commitment tracking and CAPA (corrective/preventative actions)
* To support quality assurance projects and continuous improvement activities within the affiliate across all GxP areas
* Manage the affiliate compliance training system(s)
* Support internal & supplier audits
* Affiliate Records Coordinator

Role and Responsibilities:

Affiliate QMS
* Administration of affiliate Standard Operating Procedures (SOPs) and Work Practices (WPs) within the global document management system
* Working with Process Owners to support the creation of SOPs and WPs including authoring, process mapping & formatting
* Conducting quality and compliance reviews of new procedures - providing feedback to Process Owners
* Support & administer the affiliate change control process, and tracking commitment's and CAPA (corrective/preventative actions)
* Advise on the development of training materials for new and updated procedures
* Participation in and/or leadership at the appropriate fora within the affiliate Governance & Compliance Framework

Audits & Inspection Readiness
* Participate in delivery on the annual "Quality Plan" for the affiliate including support of the annual audit programme
* Support with periodic Quality Review Audits of the affiliate and suppliers to ensure compliance and highlight risks
* Support in the preparation for and execution of corporate and Health Authority audits & inspections
* Generate reports of appropriate KPIs to demonstrate compliance levels within the affiliate

Internal affiliate development (Culture):
* As part of the Quality & Compliance team support the continuous education of the whole business on the importance of 'quality' management & support the implementation of best practices
* Responsible for delivery of intranet content & relevant communications to the organisation

Compliance Training
* Ensure the effectiveness of the affiliate quality training processes
* Manage the affiliate Compliance Training System(s) - Compliance Wire & FAST including the assignment of local training according to the Affiliate training matrix
* Set up new users within the training system and generate their curricula with line managers
* Develop & maintain the Affiliate GxP training matrix including a training analysis for new job roles
* Prepare and distribute monthly metrics and training completion reports as required
* Deliver compliance inductions for all new starters including relevant Code of Practice training for Field Force

Records Management
* Affiliate Records Coordinator- Leading records retention and ensuring good documentation practices in the affiliate

Skills and Knowledge Requirements:
* Working knowledge of the quality management principles and applicable GxP areas including:
o ABPI and IPHA Code of Practice & Healthcare Compliance
o Pharmacovigilance Legislation
o Responsibilities of a Wholesale Dealers Authorisation Holder (GDP)
* Previous relevant experience within a Pharmaceutical company (ideally at an affiliate) including relevant regulatory experience
* Highly organised and efficient. Able to multi task whilst maintaining a very high level of accuracy and attention to detail
* Solution orientated with an ability to lead projects and facilitate teams
* Experience of participating in audits and/or supporting quality reviews
* Established knowledge of good documentation and record retention principles
* Life science/pharmacy degree
* Good computer skills and good knowledge of Word, Excel, Outlook and Visio

If you are relevant or interested don't delay, contact me on 0161 924 1400 or email me at