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

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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