Quality Control Analyst
Temporary / Contract
Kelly Services, working on behalf of an International Health Care client are recruiting for an experienced Quality Control Analyst to commence in January 2021.
As Quality Control Analyst, your focus will be to Inspect and release final products as per Company policies, whilst adhering to cGMP standards at all times.
We are keen to speak with people who have the ability to work flexibly to meet the needs of the business whilst uncompromising commitment to Quality. If you have a minimum 2 years' experience in GMP environment, working within an Aseptic manufacture of medicinal products field we want to speak to you.
· Ensure continuous compliance of Compounding Unit to cGMP and "Specials" manufacturing requirements, local procedural requirements and Baxter Corporate policies;
· Support manufacture of aseptically products by making QA decisions during batch manufacturing and ensuring GMP is adhered to at all times;
· Execute documentation and batch reviews as required;
· Investigate complaints and monitor CAPAs related to them;
· Support delivery of product release targets, including ensuring timely batch review activities and batch disposition of any deviations with impact to product release;
· Ensure timely completion of all Quality System commitments;
· Support the preparation and development of Annual Product Quality reviews;
· Support validation programs and change control as required;
· Proactively identify and support implementation of continuous improvement opportunities in QA and Operations;
· Ensure timely completion of all GMP commitments;
· Ensure timely communication of significant GMP and product quality issues to QA Management;
· Comply with EHS/GMP/GDP/Company and Corporate policies and external regulatory requirements;
· Ensure facility and process compliance through attendance of Gemba activities, identifying actions and facilitate implementation;
· Implement and sustain EMS principles.
Essential duties and responsibilities listed below are included but not limited to:
· Ensure facility complies and ready for production
· Provide QA oversight to validation and product, documentation and process changes
· Update the SOP's, Instructions and processes using document change request (DCR) process and Teamcenter (TCU)
· Ensure that a schedule of environmental monitoring and equipment calibrations are in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct
· Ensure that all measuring equipment that may have an impact on product quality is calibrated to traceable standards through its life cycle, using the electronic equipment management systems and related tracking sheets;
· Review and approve planned and unplanned work.
Education & Experience
Degree or BTEC (or equivalent) in Pharmaceutical or Science related subject
Breadth & Depth of experience: 2 years' experience in GMP environment
Aseptic manufacture of medicinal products is preferred but not essential.
Field of expertise: Quality Assurance, Production, Validation, Microbiology
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.