Quality Control Analyst - Permanent Position

Main purpose of the job

This job is responsible for ensuring that all materials are tested according to agreed specifications and procedures and within agreed lead times.

To ensure that operations conducted are performed in accordance with the requirements of Eisai Corporate Standards, Eisai Quality System, GMP and GDP Guidelines and Industry Standards. 

Duties are performed to ensure:

• A safe working environment is maintained for self and other Eisai employees, ensuring all near-miss incidents and accidents are reported in accordance with procedures.
• The Quality of products manufactured and released is assured through adherence to all procedures.
• Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
• Eisai’s philosophy of hhc is at the forefront of daily activities.
• All stakeholder and customer expectations are understood and met through communication. 
• Performance is in line with personal and Eisai objectives with demonstrated behaviours and competencies.

Full time, 5 days onsite at our Hatfield office.

Main Duties / Responsibilities

• To test all materials according to agreed specifications and procedures.
• To qualify (URS, IQ, OQ, PQ) all laboratory equipment.
• To maintain and calibrate all laboratory equipment according to approved procedures.
• To maintain all laboratory Quality Systems and Quality Management Systems in compliance according to approved procedures.
• To write under supervision, all SOPs associated with QC support.
• To support the internal and external audit process and audit schedules as appropriate.
• To support the preparation and hosting of competent authority inspections.
• To raise and support the investigation of deviations and associated CAPA’s.
• To support technology transfer projects and in particular any QC aspects of these.
• To support the implementation of change control activities.
• To support the process for data collection for PQR’s.
• To support the collection of data for reporting Quality Assurance Performance Indicators.
• To support the implementation and management of stability programmes
• To perform any other appropriate duties at the request of the QC Head

Working relationships

Able to maintain working relationship and communication links within EML, affiliated organisations and third-party contractors as appropriate. Within EML, work with Quality, supply chain, manufacturing, packaging, regulatory and others to ensure that EML schedules for the release and distribution of products are met.

Skills and Qualification requirement

• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
• Extensive knowledge of Quality Control, Quality Assurance, Quality Systems, GMP, Regulatory Compliance and manufacture and packaging of pharmaceutical products
• Good technical and scientific judgement
• Ability to interpret complex data and present key findings
• Computer literate e.g. Word, Excel and PowerPoint
• Demonstrated Knowledge, understanding and application of GMP Guidelines and Regulations

Competencies required

• Diplomatic, self-motivating
• Problem solving and decision-making capabilities
• Professional behavior and self-awareness
• Good communication skills
• Good presentation skills
• Ability to work effectively within a Team
• Effective time management