Process Specialist (Maternity cover) in Wales

About Us

SERB Pharmaceuticals 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 470 employees in 16 countries and a group revenue in excess of €350m.

Our Portfolio

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

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 and appropriate training to the manufacturing team to ensure a level of process and product understanding is contained.

Principal Responsibilities

• Provide technical input into validation activities for the Production team – write, review, approve and execute studies as required.
• 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.
• Actively participate in site Operational Excellence initiatives and foster Continuous Improvement within the Production department.
• Lead process improvement initiatives and activities to influence change.
• 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 for new starters within the teams.
• Provide subject matter expert input to Regulatory, internal and external audits.
• Cover operator absence within the facility as required.
• Ensure all interactions and engagements are carried out with the highest ethical and professional standards.
• Carry out other reasonable tasks as required by the Line Manager.

These 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

• 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.
• Good listening/communication skills and able to carry out investigations by gathering information from others.
• Methodical, organised and show attention to detail.
• Strong organisational skills with an ability to plan ahead.
• Strong technical writing skills.
• Ability to communicate effectively at all levels.
• Ability to work under pressure and coordinate 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.

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.