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

  • Location:

    Hayes, London

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    £25 - £30 per hour

  • Job ref:

    BBBH103447_1557929093

  • Published:

    11 days ago

  • Duration:

    6 Months

  • Start date:

    ASAP

  • Client:

    Undisclosed Company


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

Apply Save job Create Job Alerts

Share this job