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Job Details

Senior QA Specialist FTC

Company: Clinical Professionals Ltd
Location: Slough
Reference: JO-1812-421221
Closing Date: 18 Feb 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

A global pharmaceutical company is seeking a Senior Quality Assurance for a 12 month FTC. This opportunity will be remotely based anywhere in the UK.

Requirements:

A global pharmaceutical company is seeking a Senior Quality Assurance for a 12 month FTC. This opportunity will be remotely based anywhere in the UK. The company are going through some rapid growth and are seeking an individual who can work independently and take ownership of working on CAPA's, deviations and Change controls.

The incumbent is responsible for maintaining all documents and requirements for a local drug establishment license (DEL); reviewing and approving executed batch records of finished drug product for release to market; management of samples/records; managing reference standards and retain samples; and assist with drafting product quality reviews. They will assist in development of procedures, coordinating Change Controls, CAPAs, Deviations and Complaints. The incumbent will also assist with QA Review coordination and maintaining the training program file, administrating SOPs as assigned. The incumbent will also assist the Quality Assurance department with other duties, as directed.

Please see below a brief summary of what they are looking for.


Responsibilities/Scope of Position:
Maintaining DEL documentation and requirements.
Review and approval of finished drug product batch records for release to market.
Develop a process to manage samples and documentation. Manage the samples and documents both off-site and at in line with changing company needs.
Reference standard management.
Retain sample management.
Assist in reviewing and drafting Product Quality Reviews.
Drafting and/or reviewing Standard Operating Procedures, specifications.
Assist in coordinating Change Controls, CAPAs (Corrective and Preventative Action), Deviations and Complaints.
Coordinate and perform QA review of regulatory submissions, labelling/artwork and promotional materials.
Ensuring the QMS procedures are followed. Specific activities include:Receive, assemble information related to Change Control, Complaints, CAPA, and Deviations; and notify stakeholders (i.e. internal personnel, contractors, external parties); and request relevant information/feedback. Follow-up as necessary, obtain approvals and create comprehensive reports including the supporting documents and communications. Archive all reports both electronically and in hard copy. Assist with development/improvements to workflows for quality processes. Assisting with developing and implementing written procedures for optimizing quality processes. As directed: draft, facilitate, manage, schedule, track and/or follow-up on the content, review cycle and/or approval cycle of any required documentation, records or materials (i.e. promotional material).
Assist with ensuring that all employees training records are up to date, according to the companys procedures.
Assist the SOP Administrator with document management activities as assigned.
Other duties as assigned.

Qualifications: Education and Work Experience Desirable to Perform Role
University degree, preferably with a science background.
At least 7 years of Quality Assurance experience in the pharmaceutical industry.
Excellent attention to detail and computer skills, such as Microsoft Office Suite of products and ability to learn new computer software programs.
Highly developed organizational skills and a track record of using personal initiative in developing new projects.
Demonstrated ability to work both independently and as part of a multidisciplinary team.
Excellent oral and written communication skills.
Ability to manage multiple tasks with competing priorities.
Must be able to work flexible hours potentially including evenings and weekends on occasion

Please contact Tom Quirke on 020 7822 1710 or email Thomas.Quirke@Clinicalprofessionals.co.uk to discuss this role in more detail.

Apply for this job: Senior QA Specialist FTC

Contact Information:

Address:  Clinical Professionals Ltd
33 Blagrave Street,
Reading
RG1 1PW
England
Tel:  0118 959 4990
Fax:  0118 956 0607
Website:  Visit Our Web Site

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