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Job Details

Senior QA Specialist (Manufacturing)

Company: Lonza Biologics Plc
Location: Slough
Reference: R3761
Closing Date: 29 Nov 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.  Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. ...

Requirements:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

Job Description Summary We have a great opportunity for a Senior QA Specialist to join our QA Technical Support Team based in Slough, UK. In this role you will specifically be supporting our Manufacturing department, so you will need experience of working with this functional area.

Job Description

As a Senior QA Specialist you will enable site operations performance by managing and supporting GMP issues through QMS processes, site governance mechanisms and senior QA leadership.  You will ensure site operations compliance by acting as a cGMP Subject Matter Expert and by designing, implementing, managing, and enforcing quality processes on site to encourage a ""quality at point of doing" culture.

Key Responsibilities:

  • Provide shoulder to shoulder review, approval and QA technical support to key business partners within the Manufacturing area for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations
  • Manage and escalate Major and Critical compliance issues through the site QMS processes
  • Actively identify, suggest and participate in continuous improvement activities
  • Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment
  • Maintain and promote a state of audit readiness
  • Actively suggest, initiate, participate and contribute to PQS process improvements initiatives and projects
  • Provide QA SME support at departmental Local Quality Councils and project meetings

Interested?

What we need you to have:

  • Experience of providing QA technical support to manufacturing areas
  • Significant QA experience in a GXP environment so you can act as a subject matter expert
  • Excellent communication skills with the ability to build strong relationships within the area you are supporting and across the wider site
  • Excellent risk based decision-making and problem solving skills
  • Previous QMS process design, implementation, management and utilisation experience

Responsibilities 

Education Bachelors

Work Experience

Certifications

Skills • Database familiarity with data entry/searches / queries, • Excellent organisational & planning skills, • IT literate - MS Office – Word, Explorer, Excel, Access, Outlook, • Previous QMS process design, implementation, management and utilisation experience, • Significant Scientific/GXP Knowledge

Language(s)

Lonza.  The place to Go, Stay and Grow.

Apply for this job: Senior QA Specialist (Manufacturing)

Contact Information:

Address:  Head Office
228 Bath Road Slough Berkshire
SL1 4DX
England
Tel:  +44 1753 777000
Fax:  +44 1753 777001
Website:  Visit Our Web Site

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