Quality – Process Validatiion

The Objective of the Quality Control Specialist is to:

• To liaise with Quality Management (QM), Production, Engineering, and Administration personnel to validate the different processes carried out.
• To liaise with Production, Engineering, and Administration personnel to perform quality controls and inspections.
• To contribute on the maintenance, assimilation, and consolidation of the company‘s quality management system documentation including quality templates and work instructions.
• To aid in the creation and implementation of documentation and training regarding new processes.
• To aid in all the activities necessary for audit preparations.
• To investigate and troubleshoot issues.
• Report any quality, health & safety, or environmental issues to QM or senior management personnel.
• Assist in the company’s quality management system where priorities take place such as for NCR’s, internal & external audits, quality issues, or ongoing projects.
• Closely work with QC Department in the regular review of QC documents, preparation of the annual review plan, and documentation distribution.

• • Develop and execute IQ/PQ/OQ protocols for new equipment and processes.
  • Ensure compliance with regulatory requirements (e.g., FDA, EMA).
  • Conduct IQ/PQ/OQ activities to verify equipment and process performance
  • Process Optimization:
• Identify and implement process improvements to increase efficiency, reduce costs, and improve product quality.
• • Analyze process data to identify trends and root causes of issues.
  • Develop and implement process control strategies.
• Project Management:
  • Manage equipment installation and commissioning projects.
  • Coordinate with cross-functional teams to ensure successful project implementation.

Daily and Monthly Responsibilities:

• Assist in the organisation and documentation of training programmes.
• Validation and improvement of work instructions.
• Work in cleanrooms and gown appropriately.
• Update and maintain quality documentation on the quality management system.
• Assist QM with validations, investigations, and improvement projects that are ongoing.
• Assist QM on quality related projects such as NCR‘s and lean six–sigma initiatives.
• Perform internal audits on production and engineering projects as part of the ISO 9001:2015 management system.
• Assist in the design and implementation of CAPA plans.

Desirable Requirements:

– Minimum of one year experience in a pharmaceutical/medical device/health and safety role

– Level 7 degree or higher in a Science or Engineering discipline

– Level 6/7 qualification in Quality, Process Validation or related discipline

– Previous experience in validation of manufacturing processes

– Excellent skills in Microsoft Word and Excel

– Excellent written and verbal communication skills

– Excellent documentation skills (creation, formatting, archival, retrieval)

– Excellent planning and prioritizing skills; capacity of planning ahead to ensure tasks are completed on time

– Experience in a GMP facility, in documentation role is desirable.

– High attention to detail, strong personal reliability.

Other Requirements:

– A full driving licence and ideally car ownership is required for this position as the successful candidate will need to travel between two production sites (about 10Km distance in between).

– Familiarity with SAP or other ERP system.