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

Validation plays a critical role in the manufacturing process, executing the testing and qualification of GxP systems. This entails the verification of quality systems to make sure that they function according to specifications set by the user and external regulatory bodies.

This role requires the delivery of validation activities to support manufacturing at the Wales site, ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities. A member of the validation team who provides direct support to the efficient delivery of the Site Validation Master Plan (SVMP) Schedule. 

Principle Responsibilities

1. Responsible for the completion of assigned validation activities on time in accordance with the SVMP schedule.
2. Generation of related project documentation and protocols for installation, operation and performance qualifications, Validation plans and reports
3. Execution of validation testing for manufacturing equipment, utility systems equipment, processes, cleaning validation, product hold times, and any other study identified in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.
4. To follow all Standard Operating Procedures (SOP’s), Quality Records (QRs) and Batch Manufacturing Records (BMRs) and to participate in the generation, completion and review of such documentation when required, to agreed timelines.
5. To document all EHS incidents and cGMP events to agreed timelines using the required business systems.
6. To participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.
7. Liase with external contractors to arrange the completion of PPM activities, and the subsequent administration of PPM to closure
8. Supports the administration requirements for Validation documentation during Regulatory Inspections.
9. Supports internal audits where required, taking responsibility for the closure of assigned actions in a timely manner.
10. Continuously look to support continuous validation improvement activities.
11. Support other departmental activities as requested by department management or designate.
12. Ensure that all interactions and engagements are carried out in accordance with Serb DNA and that all work is accomplished with quality and in accordance with the Company values.
13. Carry out other reasonable tasks as required by the Line Manager.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Education and Experience

• Educated to GCSE – HND/C standard in a relevant Science subject and / or experience of working in a manufacturing environment that employs a quality system (cGMP, ISO9001).
• Understanding or can show awareness of cGMP and EHS practices.
• An understanding of Lean Manufacturing principles and the application of 5S desirable.
• Computer literate.

Skills and Attributes

• High standards of attention to detail and the desire to see tasks through to completion.
• Must have good listening skills and be able to follow instructions and guidance.
• Must be able to work as part of a team and demonstrate initiative, when required.
• Must be able to train others and deliver clear instruction, when required.
• 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.