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QA Officer - GMP - West London

Employer
Umbilical Life
Location
London (Central), London (Greater) (GB)
Salary
Negotiable
Start date
26 Sep 2019
Closing date
26 Oct 2019

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Discipline
Quality, GMP
Hours
Part Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Michael Parker at Umbilical Life is recruiting a Senior QA Officer in an expanding Pharmaceutical company based in London.

Working with a market leader, the company is renowned for its innovative products. You will be supporting them across GXP. The company is in the process of bringing in 6 newly acquired products that are all sterile. You will be able to travel to manufacturing sites globally and really implement change, whilst harmonising QA.

The role has huge growth potential, with the most successful candidates having a can-do attitude.

Responsibilities and Key Tasks

  • Work with the QA Manager to ensure that GMP/GDP training is up to date and assist with the implementation of the training program;
  • Assist in building and maintaining a strong Quality culture throughout the UK & EU;
  • Provide support to create and maintain company quality documentation;
  • Provide support in the artwork approval cycle;
  • Follow up on Quality Issues to ensure timely close out of actions and ensure status visibility;
  • Support internal audit program on the onsite audits and the external audit program on supplier audits;
  • Provide support on recalls, complaints, CAPAs, change controls and deviations/OOS results;
  • Perform batch documentation review to support the batch release process;
  • Provide data to support the quality management review;
  • Perform analytical trending on the EU QC testing results for product imported from outside of the EU;
  • Collect data and maintain the technical product files;
  • Maintain departmental databases as appropriate;
  • Provide day-to-day departmental/project support activities;
  • Act as quality point of contact for the warehouse.

 

 

Key Skills

  • Good technical knowledge of EU GMP, regulations and guidelines;
  • Highly collaborative, regular interaction with the named QP, Regulatory groups, QPPV, Supply chain, site based QA, distributors, testing labs, warehouses, sales departments, customers, MA holders and regulators;
  • Ability to work independently with limited supervision, self-driven, responsive and results orientated;
  • GMP auditing knowledge and practical skills, both hosting and performing;
  • Good team player, positive attitude and the ability to be flexible;
  • Ability to work under pressure in a fast moving work environment.

Qualification Requirements

  • Minimum a BCS degree in life science;
  • Minimum 5 years’ experience in a similar Quality Assurance role within the Pharmaceutical Industry;
  • Minimum 2 years’ experience gained through batch review;
  • Relevant GMP training as required to discharge assigned duties and responsibilities;
  • Good knowledge of MS Office and Minitab application is desirable.

Working Conditions

Office based working environment, availability to travel up to 15% of the time;

The positions will report into the Quality Manager.

For a confidential discussion please contact Michael at Umbilical

on +44 (0) 116 461 0070 or email Michael.Parker@Umbilical-Life.com

Company

Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering. 

Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.

With nearly 75 years of workforce industry experience between us we know a lot, but not everything. 

We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.   

 

Company info
Website
Telephone
011 6 461 0070
Location
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom

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