Career Opportunities Getinge Group Quality Control Supervisor

Job Title: Quality Control Supervisor

Location: Getinge Head Office Derby

Getinge UKI are seeking a methodical and due-diligent Quality Control this exciting role youll take ownership of the supervision of all aspects and functions of the Quality Control Lab to support the manufacture and release of regulated products into global markets in accordance with their registered specifications. Additionally as part of the wider Quality team this role will be responsible for taking the lead on investigations and be a champion for good manufacturing practice.

Key duties and responsibilites:

Supervise be an escalation point for and perform as necessary the following daily Quality Control Activities:

• QC testing for raw materials in process goods and finished products in accordance with defined procedures.
• Issuance of batch sheets batch labels and product labels in accordance with operational requirements.
• Generation of COAs and other batch related documentation.
• Input of required information into the local ERP system ensuring data integrity including batch yield information and the adjustment of any production losses.
• Finished product batch release activities.
• Management of label stores.
• Retained samples are stored and controlled appropriately.

Conduct and ensure compliance of the following:

• Lab equipment is maintained and calibrated according to approved procedures.
• That QC documentation methods procedures protocols and reports are effective up to date and trained out. Support validation of analytical methods.
• Archiving of batch records ensuring data integrity and data review as and when necessary.
• Reporting on batch non-conformances and out of spec results conduct investigations in the lab and factory including investigatory testing to determine root causes and implement effective corrective and preventative actions maintain good documentation and log as appropriate.
• Control and impose production holds as necessary relating to Quality issues.
• Established KPIs are reported on and data analysis is performed as necessary to identify trends in test results including first time pass rates
• Ensure that stock of QC lab consumables reagents and standard samples are ordered and replenished in a timely manner.
• Present QC Operation and related data during Competent Authority Notified Body Internal and other audits as well as local meetings.
• Provide SME support to the Operations teams in the factory to help seamlessly resolve issues and continue efficient production.

Lead and Support in the following other business critical areas:

• Coordination of calibration activities across the organization keeping the business tracker up to date and coordinating with equipment owners to ensure continued compliance
• Control non-conforming material by administering appropriate labelling and records of quarantined stock to support disposition decision making
• Supervise rework activities where necessary ensuring appropriate instructions training and documentation is provided to operators to ensure compliant rework and release of reworked goods.
• Lead on process validation activities within the lab and factory acting as an input into new processes and working with subject matter experts to ensure processes are validated for consistent outcomes.

Who you are:

At Getinge we are looking for passionate individualswho are agile resilient take responsibility for their development and focus on achieving excellence. They never compromise on quality and always act responsibly remembering that our customers always come enjoy collaboration and working in diverse and international teams and embrace the future.

If you love change we can make sure that you stay that way!

Knowledge Skills and Experience:

• Relevant scientific degree or equivalent in a related discipline is highly advantageous but not essential
• Minimum 1 years experience in a regulated industry performing analytical chemical testing and general product/process quality control is preferred.
• Knowledge of medical device quality related frameworks such as ISO 13485 Medical Device Regulation 21 CFR part 820 is desirable although consideration would be given to candidates with similar experience in chemical pharmaceutical food cosmetic automotive industries with translatable skills.
• Strong IT skills

Personal qualities:

• Ability to work in a fast-paced environment with strict deadlines.
• Great written and verbal communication skills as you will need to engage positively with different stakeholders across the business.
• Methodical thinker that can analyse and evaluate root causes of issues.
• Takes pride in generating detailed high-quality documentation that is engaging and audit ready.
• Accountability - provide clear and accurate data regarding product and process measurables.
• Demonstrate good judgement and decision making that is required for effective problem solving.
• Enthusiasm to drive continuous improvement.
• Demonstrable leadership qualities and ability to bring others along to perform functional fast-paced tasks.

What we offer:

We offer a competitivecompensation and benefitspackage to ensure we support your well-being and understand that a healthy work-life balance is important so we offer aflexibleapproach to working patterns as well as a range of enhancedfamily friendlypolicies.

Along with a competitivesalarywe offerprivate healthcareshoppingdiscountsthrough Perkbox and anEmployee Assistance Programme. We have achieved the Better Health at Work Scheme Gold Award through providing a range of resources meetings activities and training to employees to support their physical and mentalhealth and wellbeing.