Equipment Qualification Assistant

Come and Save Lives with Us!

The Company is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 400 employees in 10 countries.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority    
• We act with integrity and accountability 
• We work together as one team  
• We look for better ways forward

Broad Function
To provide hands-on support to the validation team in the execution and completion of pre-approved validation protocols, and completion of associated administrative duties at the Wales site.
All training will be provided for this role. This role will allow for progression into the validation technician role for the right candidate.  

Principal Responsibilities

1.    To support in the execution and completion of assigned validation activities on time in accordance with the SVMP schedule.
2.    To follow all Standard Operating Procedures (SOP’s), Validation Protocols and Batch Manufacturing Records (BMRs) as required.
3.    Co-ordinate departmental preventative maintenance (PM), inclusive of scheduling and shipping equipment for calibration/ PM. 
4.    Support the administration requirements for Validation documentation, inclusive of archiving, filling, and printing following local procedures.
5.    To support in the execution of validation testing. This shall include but is not limited to testing of manufacturing equipment, autoclaves, utility systems equipment, cleanrooms and temperature controlled units. 
6.    Undertake validation studies in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control. 
7.    To document all EHS incidents and cGMP events to agreed timelines using the required business systems.
 

Education and Experience
1.    Educated to GCSE – HND/C standard desirable, or and / or relevant experience
2.    Understanding or can show awareness of cGMP and EHS practices.
3.    Must be Computer literate.

Skills and Attributes

1.    The ideal candidate will have a willing and hands on attitude.  
2.    High standards of attention to detail and the desire to see tasks through to completion.
3.    Demonstrated to be bright with a strong willingness to learn
4.    Must have good listening skills and be able to follow instructions and guidance.
5.    Must be able to work as part of a team and demonstrate initiative, when required. 
6.    Must be Methodical, organized with an aptitude for detail. 
7.    Must have a flexible, positive and willing attitude at all times.
 

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.