Quality Systems Specialist

4 weeks ago


Widnes, Halton, United Kingdom Teva Full time
Company Overview
Teva is a leading manufacturer of generic medicines, with a rich history of innovation and dedication to making good health more affordable and accessible.

The company has a strong commitment to quality and regulatory compliance, ensuring that our products meet the highest standards for safety and efficacy.

As a Quality Compliance and Systems Officer at Teva, you will play a key role in supporting the business in maintaining its high standards of quality and regulatory compliance.

Salary
We offer a competitive salary of £35,000-£45,000 per annum, depending on experience.

About the Role
This exciting opportunity is available within our Quality Compliance and Systems team, where you will be responsible for providing guidance and support to the business in maintaining quality system processes and associated documentation.

You will manage and maintain quality system processes and associated documentation to ensure compliance with regulatory standards and corporate expectations. This includes but is not limited to:

* Complaint Management

* Product Quality Reports

* Document Control

* Internal & External Audit

* QMS performance i.e. KPI's, SQC, Annual Reports etc.

* Issue and control CGMP documentation to support business activity.

* Support continuous improvement of quality documentation and processes to ensure compliance with CGMP.

* Deliver CGMP and Quality Systems training in line with Site requirements.

* You will carry out internal and external audits in line with plan. To act as lead auditor, to identify, action and close out all non-compliance issues with adherence to schedule.

* Maintain and update information on latest Regulatory standards for use by company personnel.

Required Skills and Qualifications
To succeed in this role, you will need:

* Relevant experience working in a Quality role within the Pharmaceutical Industry

* Full understanding of cGMP, ideally Pharmaceutical GMP regulations (EU & USA)

* A good knowledge of Quality System Processes (such as Change Control, Deviation, Document Control and CAPA etc.)

Additionally, you should have:

* Degree level educated (although not essential)

* A confident communicator and able to prioritise effectively and work to tight deadlines

* IT Literate with good report writing and audit skills

Benefits
We offer a range of benefits, including:

* 25 paid holidays per year with the option to buy and sell up to 5 days annual leave each year

* Private healthcare scheme through Bupa

* A formal training and development programme specific to your role and department

* Company pension - flexible employee and employer contributions

* Competitive salary

* Employee assistance programme

* A number of health benefits including: Life Assurance, Critical Illness Insurance, Income protection

* Plus many other flexible benefits via salary sacrifice: Cycle to work scheme, online and in store discounts and much more

Reports To
You will report directly to the Quality Compliance and Systems Team Leader.

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