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Job Details

Qualified Person

Company: Lonza Biologics Plc
Location: Slough
Reference: TR5TJ
Closing Date: 03 Jan 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 SummaryTo undertake the duties of a Qualified Person as defined in Directives 2001/83/EC as amended and 2001/20/EC and be responsible for review of relevant documentation associated with the manufacture and testing of Drug Substance and Drug Product Intermediates. Also to be responsible for the QP certification of Drug Product Intermediates in accordance with UK Code of Conduct for Qualified Persons.

 

Job Description
  • Be responsible for recording batches released in the QP Register.
  • Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Pharmaceutical Quality System (PQS).
  • Supporting senior QA and site leadership through QP and Quality decision making to drive continuous improvement and ‘fitness for purpose’.
  • Work with the Head of Quality to maintain and improve all activities directly and indirectly relating to QP certification and batch release
  • Acting as a point of contact for queries relating to QP certification and batch release
  • Support Senior Quality Associates and QA (Operations) Team Leader  roles when workload, department or site needs dictate
  • Ensure that all processes and procedures that are required for QP certification / batch release of drug substance are fit for purpose.
  • Apply GMP regulations consistently. Expand compliance knowledge base and mentor others to expand on-site compliance knowledge.
  • Support regulatory, corporate and customer audits of the site as well as proactively support customers’ needs and provide timely responses to queries and communications
  • Act as a single point of contact in interactions between QA and internal Lonza functions and external customers and third parties as required

Responsibilities 

EducationBachelors (Required)

 

Work ExperienceQuality

Experience Level

Advanced

CertificationsQP - Joint Professional Bodies

 

SkillsAbility to work independently in a team environment, Ability to work in team and solo capacity., Biologics, cGMP manufacturing, Good organizational and planning abilities, Sterile processing/ Production in GMP regulated area

 

Language(s)English

 

 

 

Lonza.  The place to Go, Stay and Grow.

Apply for this job: Qualified Person

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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