QA Associate / Aseptic Technician |Negotiable
Allied Health Professionals & Health Sciences
Pharmacy
Permanent
South East

Location: Oxford
Salary: £32,000
Hours: 8am-4pm 10am-6pm (Weekly shift rotation)
Job Type: Permanent

Summary

* Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality.
* Responsible for release of product from the system.
* Responsible for supporting production in the review and post compounding check operations.
* Responsible for implementation and management of the companies quality system within the compound unit.
* Ensuring regulatory compliance.
* Ensure that unit is compliant with all corporate quality system policies and procedures.
* Responsible for review of the implementation of the company Quality System to initiate, and drive continuous improvement

Key Responsibilities

1. Post Compounding check and Release
o Responsible for the Review of prescriptions on Merlin
o Responsible for release activities associated with products manufactured at the compounding units.
1. Change Control
o Maintain a local change control process to ensure all changes are fully documented
o Ensuring all changes are assessed for risk and impact prior to implementation
o Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame
2. Validation
o Management of the site Validation Master Plan
o Ensuring all equipment used for the manufacture and storage of product is validated before use
o Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.
3. GMP and Facilities and Equipment Control
o Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
o Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete
o Investigation of out of limits results using exception and CAPA processes
o Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
4. Quality System Measurement and Review
o Ensure outcomes, decisions and actions of the review are documented
o Ensure meeting actions are completed to agreed deadlines
o Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
5. Complaints
o Ensures all incidents reported by customers are appropriately documented and investigated
o Management of complaints using TW8
o Responsible for reporting any complaints that may result in Field Corrective Action immediately to the Business management representative and also the European FCA gatekeeper
8. Audit Management
o Ensures that the facility is always ready for an internal, corporate, MHRA or 3rd party audit
o Manages the audit process for the facility, organization of the management team and staff to ensure a successful audit
o Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue
9. Communication and Training
o Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance

Experience

Breadth & Depth of experience 2 years experience of working in a aseptic compounding operation
12 months experience of quality system implementation
Field of expertise: Ideally experience in all or any of the following:
Quality system management and implementation
Environmental / microbiological control
Validation
Risk management

If you are interested in this position or would like to hear more information then please call Daniel on 0208 364 9911. Alternatively you can email me on daniel.marie@sensible-staffing.com 

We act as an employment business to provide temporary staff and an employment agency to provide permanent staff.

If you are applying for the first time, please complete all fields below

Already registered with Sensible Staffing? Just enter your name, contact number and email.

attach
attach

Do you know someone who you think will be ideal for this position?

Complete the simple form below to send these details to your friend.

Sensible Staffing are fully committed to protecting any personal information that you choose to share with us via our website or through any means of correspondence.

What information do we collect?

We will collect and retain any personal data that you choose to send us using the online forms on our website. This information will only be used in accordance with our privacy policy and to provide you with a service or to answer your enquiry.

Sensible Staffing is part of the Pario Group of companies. At no stage will we disclose your information to a third party company outside of the Pario Group of companies and will use the appropriate security measures to ensure that all data remains private.

This also applies to any correspondence made by fax, phone or email.

Website Statistics

We track all visits to our website so that we can monitor usage and preferences to help us provide a better service and online experience for our users. Information we collect relates to referral websites, search engines and your personal IP address. We do not use this information to identify you as an individual and you will remain anonymous.

Cookies

Cookies are small files stored within your web browser from our website. Cookies do not collect or contain any personal information about you nor do they allow us to access your computer in any way, shape or form.

We use cookies to identify website usage and for statistical and analytical purposes only. All information is collected lawfully and in accordance with the Data Protection Act 1998.

Your Rights

Please note that in agreeing to share these details you have not forfeited your rights as outlined under the Data Protection Act 1998.