Quality Systems Associate
This job is responsible for ensuring that operations carried out within the Quality Systems section are completed in accordance with the requirements of the departmental Standard Operating Procedures.
Support the effective running of the Product Quality Review, Quality Agreements, Complaints, Deviations, Parallel Imports, Risk Management, Qualification and Validation, Training, Standard Operating Procedures, Internal and External Audits and Approved Supplier Systems.
Ensure EMLs Electronic TrackWise Quality Management System (QMS) and any associated systems used for the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and
Corporate expectations. Provide input to the review and writing of any associated quality policies, systems and procedures as required. Support the generation of routine status and performance reports covering aspects of EMLs Electronic TrackWise QMS.
Support the Quality Systems Manager with activities related to the maintenance of the Regional Quality System for the Europe, Middle East and Africa (EMEA) region, to ensure that products are managed and distributed in line with the Regional Quality System Procedures.
General Responsibilities (Safety, Quality, Customer, Cost and Innovation)
Standard clauses for all EML employees:
To ensure that operations conducted are performed in accordance with the requirements of the company's Corporate Standards, Quality System, GMP and GDP Guidelines and Industry Standards.
Duties are performed to ensure:
A safe working environment is maintained for self and other 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.
The company'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 objectives with demonstrated behaviours and competencies.
This position has working relationships with the following:
All EML departments
EEL departments including: Pharmacovigilance, Global Regulatory Affairs, Growth Markets, Legal, Medical Information, EMEA Controlled Documents
External suppliers and affiliated organisations
Job Specific Responsibilities
Details of responsibilities:
To support the Product Quality Review process for EML.
To support the process of generation of Quality Agreements.
To support the process for approving suppliers and the maintenance of the Approved Suppliers List.
To support the Complaints process of logging, review and investigation of Product Quality Complaints.
To support the maintenance of a list of Parallel Importers/Distributors of products as compiled from notifications and samples received by
To support the generation of the Quality Management Systems Indicator reports.
To support the ongoing operation, maintenance and implementation of improvements to TrackWise processes and systems to meet EMLs needs.
To support EMLs Training Management System.
To maintain copies of Corporate Policies, Guideline, Standards and Procedures.
To write and review all SOPs associated with the Electronic TrackWise QMS
To support the EML SOP System.
To support the internal and external audit process and audit schedules
To participate in Audits
To support the EML Change Control System
To support the review and approval of Qualification and Validation documentation
To support the control of Regulatory Information within EML
To support Quality Systems training of EML staff, as required.
To coordinate and support GMP Training
To support the Deviations System
To support the EML Risk Management System
To provide day to day support to other members of the Quality Systems team, as appropriate.
Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working
To perform any appropriate duties at the request of the Quality Systems Manager.
Skills / Qualifications
Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
Basic knowledge of Quality Assurance, Quality Systems, GMP and basic understanding of 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
Basic understanding of GMP Guidelines and Regulations
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
To find out more please call Tom Quirke on 020 7822 1710 or email me on Thomas.Quirke@Clinicalprofessionals.co.uk