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Job Details

QA Compliance Associate / Senior QA Compliance Associate

Company: Chiltern
Location: Officed based in Slough, Berkshire, UK
Reference: JT-900046
Closing Date: 21 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Chiltern are looking to recruit a permanent full time QA Compliance Associate / Senior QA Compliance Associate to be based at our offices in Slough, UK. This position will support the Document Control group within the Quality Assurance & Compliance Department.

Requirements:

Job Background

Training will be provided, however any previous experience of roles including Document Control responsibilities; exposure to Quality Management Systems; and/or Quality Assurance would be an advantage.

Successful candidates will have the opportunity to be part of a growing company with a strong brand of professional employees that care about the work they are involved in. Chiltern is constantly working to develop training capacity, therapeutic expertise, new technologies and processes to be one of the leading CROs globally.

We can offer competitive salaries, benefits that are designed around you, a strong support mechanism and dedicated coaching to develop your career.

  • Assist with the formatting, tracking, revision, quality control, maintenance, publishing and archiving of Chiltern Standard Operating Procedures (SOPs) and controlled documents.
  • Assist with the distribution of documents for cross functional review.
  • Assist with updating the internal intranet site with all forthcoming and effective documents, and communicate to relevant employees accordingly.
  • Assist with sending Chiltern SOPs and controlled documents outside of the organisation to Sponsors/Contractors.
  • Assist with maintaining the Controlled Document Issue Log, ensuring any issues that can be addressed during SOP revisions are implemented.
  • Depending on experience, serve as a mentor to less experienced members of the team and assume coordination responsibilities assigned to support QA management. 

Other responsibilities that may be associated with the role include:

  • Support the Audit/Inspection Host or QA Facilitator with preparation, hosting and follow-up of Sponsor Audits or Regulatory Inspections of Chiltern (and Investigator sites), sometimes serving in the capacity as an Audit Host, where designated.
  • Support tracking of GCP Escalation Committee (GEC) escalations, meetings and resulting actions in the electronic Quality Management System (eQMS).
  • Responsible for entry, quality control and resolution of CAPAs and quality initiated actions.
  • Perform entry and quality control of SOP deviations.
  • Perform quality data analysis, trending and reporting activities.
  • Partake in quality improvement initiatives and projects, as assigned.
  • Support development, implementation, maintenance and support of Chiltern’s electronic Quality Management System (eQMS).
  • Perform tracking and reporting customer complaints.
  • Support the implementation of Quality Agreements and Quality Plan, and any resulting training materials for the project team and QA personnel.
  • Support the collation and reporting of quality metrics.
  • Support established risk management strategies.
  • Perform processing, tracking and storage of blinded project materials (e.g. randomisation schedules, code break envelopes), when utilised.
  • Assist with drafting of new or revised QA controlled documents.

Skills:

  • Minimum 2-4 years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Ability to speak and conduct oneself in a professional manner
  • Desire and ability to learn and take on new tasks.
  • Diplomatic and professional oral and written communication skills.
  • Good attention to detail
  • Ability to proactively manage multiple tasks
  • Experience working in a team environment under time and resource pressures.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
  • Ability to guide, supervise and motivate less experienced staff
  • Ability to train junior members of the QA Compliance team on relevant QA systems, processes and procedures 

Additional Information:

  • This is a full time permanent position, office based in Slough.
  • For a confidential discussion about this opportunity, please phone 01753 216725.

To apply, please send your CV to julia.thomson@chiltern.com - julia.thomson@chiltern.com

For more information about Chiltern International, please visit our web site at www.chiltern.com

Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,300, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®. 

Please note that if your experience does not mirror that of our requirements for this role you may not receive a response

Salary

Competitive

Position Type

Permanent
Full Time

Contact

Email Julia Thomson - Julia.Thomson@chiltern.com
+44 (0) 1753 216 725

Apply for this job: QA Compliance Associate / Senior QA Compliance Associate

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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