CCS and Cleaning Validation

Jobinhalt

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a CCS and Cleaning Validation to support our projects in Taiwan.
You will be responsible for:

• Execution of the site’s Sterility Assurance Strategy and Practices in collaboration with other Business Stakeholders, including:
  • Facility Design
  • Media Fill Testing
  • HEPA filter certification
  • Smoke Testing
  • Facility & Area Cleaning and Disinfection Program
  • Gowning
  • Aseptic Practices and techniques, including training of staff
  • Environmental Monitoring (viable and non-viable)
  • Contamination Control & Bioburden Containment
  • Ensure the proper issuing of Sterility Assurance documentation to support the product release
  • Contamination Control Strategy, including:
    • implementation and monitoring of the company contamination control plan
    • write and review documentation such as (risk assessments, gap assessments, issuing and periodic updating of the company contamination control strategy document)
    • implementation and periodic review of the contamination control strategy management procedure
    • participation in internal and external audits
    • definition of new metrics and monitoring of existing ones to support CCS
    • participation in continuous improvement program
    • write and review documentation such as (risk assessments, gap assessments, issuing and periodic updating of the company contamination control strategy document)
    • implementation and periodic review of the contamination control strategy management procedure
    • definition of new metrics and monitoring of existing ones to support CCS
• Supporting the definition and execution of the site’s Sterility Assurance Strategy and Practices in collaboration with the Sterility Assurance Team and with other Business Stakeholders
• Familiarity with GMP Regulations and Guidances associated to Sterility Assurance and Microbiology
• A detailed understanding of the QMS/PQS with proven experience in Change Controls, Deviaitons, CAPAs, and Investigatios.
• Ensure Adequate Sterility Assurance related Deviation Investigation and Change Control Management
• Implementation, maintenance, continuous improvement and innovation of Practices, Processes, and Systems that are effective, practical, robust yet agile to ensure the Sterility Assurance Strategy is executed and leads to "being continuously in control”
• Support implementation of new technologies related to Sterility Assurance
• Writing and approving periodical trending reports including CAPA decisions in collaboration with Business Stakeholders
• Supporting Sterility Assurance related Deviation Investigations (Impact Assessments & Root Cause Analysis) and Change Controls
• In collaboration with Business Stakeholders, define CAPA and Support implementation
• Help organizing the Site Sterility Assurance Review Board
• Drive/Support review and implementation of Regulations
• Regularly GEMBA the Aseptic Practices and Environmental Monitoring Practices on the shop-floor to ensure adherence to implemented Standard Practices, Processes and Systems by all site personnel
• Continuous improvement of these Practices, Processes, Systems and Trainings
• Support the Environmental Monitoring Control activities (sampling, sample delivery to QC, reporting, excursion management)
• Support Audits & Inspections
• Collaborate with and be able to coordinate the work of SA/EMC Officer

Cleaning part :

• Apply technical expertise to define proper cleaning validation strategies based on a product’s dosage form, chemical properties, manufacturing processes, and the site’s current cleaning validation matrix data.
• Applies Quality Risk Management principles to products and equipment to define a suitable cleaning validation strategy Prepares cleaning verification and validation related documentation (e.g., protocols, reports, and matrix assessments).
• Monitors cleaning validation status for each active ingredient, detergent, and piece of equipment and coordinates with operations department to define post-production swabbing requirements.
• Supports change control/new product introduction, cleaning procedure development, and swab method development activities as a technical SMEs
  

Requirements:

• Bachelor or Master Degree in Lifesciences or experience acquired through previous roles/missions
• Between 5/10 years experience in Quality Assurance and Sterile Quality Control within Pharmaceutical Manufacturing.
• Be an expert in Sterility
• Fluent English, Mandarin is a plus
• Demonstrated Microbiological knowledge and experience
• Ability to influence others / convey ideas and opinions
• Capability to understand "product-patient-illness-treatment”-relation and ability to assess health risks and impacts as well as compliance and financial risks
• Ability to perform effective Impact Assessments and Root Cause Analysis
• Effective Document Creation skills (SOPs, instructions and other standards)
• Ability to visualize performance using data / ability to interpret data
• Speaks-up in a constructive manner, even in front of (senior) leader

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.
If you are looking for arewarding and exciting career, PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.