QA Technician

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Role

A new vacancy is available for a Quality Assurance Technician.  The Quality Assurance Technician will support the QA team in delivering an effective quality management system (QMS) in compliance with ICHQ7, ISO9001:2015 and associated regulations. 

The role requires the individual to support and maintain some or several quality systems elements which includes: Batch Release, Change Control, Validation, Supplier Quality, Customer Support/Complaints, Documentation, Deviations, CAPA and Auditing

The role will require strong collaboration, elements of problem solving, technical writing and use of digital QMS tools on a daily basis.  Effective team work is critical to this fast paced dynamic role. 

Duties 

• Review and approval of batch related documentation and final product release. 
• Investigation reporting including Process Deviations, OOS, Material Failures and Customer Complaints analyzing possible solutions using standard procedures and solving routine issues that arise.
• Use of Trackwise/Veeva Deviation, CAPA, Audit, Complaint and Change Control modules to support day to day tasks in QA.
• Preparation of Annual Product Reviews. 
• Administration and maintenance of the Documentation system. 
• Oversight and management of the Documentation Archive. 
• Participate in Customer site audits including assistance with preparation of CAPA Plan audit responses.
• Support supplier approval process 
• Monitor and action Kelsius temperature monitoring system on a rotational basis.
• Conducting internal cGMP audits and tracking completion of corrective actions. 
• Develop and maintain metrics systems to provide feedback on Quality performance. 
• Participate in Site Validation activities including Process, Cleaning and Equipment validation, building knowledge of processes.
• Drafting of SOP’s, Monographs and Master Batch Records. 
• Completion of Customer questionnaires and other miscellaneous queries. 
• Support the roll out of Emprove products. 
• Carrying out all tasks with a moderate level of guidance and direction.

Who You Are

Essential: Certificate Qualification- Science/Chemistry Engineering Discipline or equivalent experience in a pharmaceutical environment
Desirable: Degree Qualification –Science / Chemistry discipline or equivalent experience with relevant regulatory experience
Previous experience in Quality role, in a Regulated FDA Environment.
Knowledge of New product introduction (NPI), Risk Management process, Deviation, CAPA, Audit,
Change Control and Customer complaint Trackwise Modules , SAP & LIMS
Comprehensive understanding and application of QMS in the Life Science industry,EU Pharmaceutical
Legislation & EU regulatory Systems ICH Q7 and ISO 9001:2015 principles desireable
Proven track record working in a dynamic fast paced team environment

Ad hoc duties can be assigned as part of the role

Knowledge and Skills:
•    Strong interpersonal, communication and leadership skills
•    Good computer literacy 
•    Moderate technical writing capability 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!