Process Specialist Wales
Job description
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
Responsible for providing technical expertise to the Production team. Responsible for providing appropriate training to the manufacturing team to ensure level of process and product understanding is contained.
Principle Responsibilities
Provide technical input into validation activities for the Production team – write, review, approve and execute studies as required.
To perform administrative tasks and provide rapid issue resolution for all electronic manufacturing systems, including EAMS, MES and computerized processing equipment controlling systems.
Work alongside internal & external functions to transfer new equipment and techniques effectively & efficiently to production scale.
Active participant for site Operational Excellence initiatives. To foster and encourage Continuous Improvement within the Production department. Lead process improvement initiatives and activities to influence change.
To actively maintain and update knowledge and expertise of current developments, standards and operating practices within the biotechnology and pharmaceutical industries
Input into the Regulatory strategy and author the relevant sections of Regulatory dossiers to support both Changes & Deviations.
Ensure practical training modules are in place so that new starters within the teams are provided with sufficient background understanding and knowledge before entering into their roles. Responsible for the provision of training to new starters and for robust re-training modules to maintain a high compliance within the teams.
Provide subject matter expert input to Regulatory, internal and external audits.
Cover operator absence within the facility as required.
Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values.
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.
Principal Relationships
Responsible for:
N/A
Internal:
Interaction with internal personnel at all levels of the business as required.
External:
Liaise with external personnel as required.
Education and Experience
Educated to degree level in an appropriate scientific discipline.
Significant experience in a biopharmaceutical or closely related industry.
Excellent understanding of cGMP legislation
Computer literate
Skills and Attributes
Strong technical background with an excellent working knowledge of GMP, Quality and Regulatory understanding.
Must have good listening/communication skills and be able to carry out investigations by gathering information from others.
Needs to be methodical, organised and show attention to detail. Organisational skills should be strong with an ability to plan ahead
Strong technical writing skills
Ability to communicate effectively at all levels
Ability to work under pressure and co-ordinate several activities concurrently.
Project management capabilities
Strong presentation skills
Logical and numerate with an aptitude for detail.
A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward.
S erb 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.
