AddressJob Requisition ID: 32142
Department: 503 COGs - Production - Equipment Prep (503)
Category: Production
Location: Wales
Date: 2 Mar 2024
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 16 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 manufacture bio-pharmaceuticals, intermediates and other products to defined standards of quality, GMP and safety. A member of the production team who provides direct support to the efficient running of the manufacturing area and thereby ensuring the manufacturing schedule is met.
To manufacture bio-pharmaceuticals, intermediates and other products to defined standards of quality, GMP and safety. A member of the production team who provides direct support to the efficient running of the manufacturing area and thereby ensuring the manufacturing schedule is met.
Principle Responsibilities
1. To ensure that the manufacturing facility and the activities that take place within it are all compliant with cGMP and EHS regulations, at all times.
2. To proactively support the production team to meet the manufacturing schedule.
3. To perform and record cleaning of process equipment and plant in accordance with relevant documentation and procedures.
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 conduct accurate batch manufacturing data collection activities and ensure such data collection tools are maintained at all times.
6. To document all EHS incidents and cGMP events to agreed timelines using the required business systems.
7. To participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.
8. Carry out quality and safety audits as directed by the Senior Production Technician.
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.
1. To ensure that the manufacturing facility and the activities that take place within it are all compliant with cGMP and EHS regulations, at all times.
2. To proactively support the production team to meet the manufacturing schedule.
3. To perform and record cleaning of process equipment and plant in accordance with relevant documentation and procedures.
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 conduct accurate batch manufacturing data collection activities and ensure such data collection tools are maintained at all times.
6. To document all EHS incidents and cGMP events to agreed timelines using the required business systems.
7. To participate in subsequent root cause investigations and perform corrective and preventative activities that may be assigned, on time.
8. Carry out quality and safety audits as directed by the Senior Production Technician.
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
- Ideally 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).
- A good understanding of cGMP and EHS practices.
- An understanding of Lean Manufacturing principles and the application of 5S desirable.
- Computer literate.
Skills and Attributes
- I Must have good listening skills and be able to follow instructions and guidance.
- Needs to be methodical, organised and show attention to detail.
- 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.
