Process Development Specialist

21 hours ago

Sligo, Sligo, Ireland beBeeDevelopment Full time €80,000 - €100,000
Process Development Specialist

The Process Development Specialist will play a key role in our Quality department, focusing on the successful transfer of processes and technology.


Key Responsibilities:
  • Plan and coordinate process development activities to support new product introductions and product support.
  • Develop comprehensive instructions for production operations, including tableting and packaging.
  • Review and analyze process data, working closely with the scheduling team to ensure timely execution.
  • Provide ongoing support to the Manufacturing team throughout the manufacturing process and develop necessary protocols.
  • Apply a risk-based approach for planning, readiness, and execution of process development activities.
  • Develop strategic partnerships with site business units to address process-related issues.
  • Offer on-the-floor process guidance and introduce statistically based tracking metrics.
  • Monitor critical process parameters and update process databases regularly.
  • Investigate and resolve non-conformances, deviations, and change control requests.
  • Perform sample analysis and coordinate external test laboratories when required.
  • Present process issues and develop business cases for courses of action as appropriate.
  • Support Quality and Regulatory Audits.

Required Skills and Qualifications:
• Strong technical knowledge of pharmaceutical processes and regulations
• Excellent communication and project management skills
• Ability to work effectively in a fast-paced environment
• Strong analytical and problem-solving skills
• Experience with process development and technical transfer
• Familiarity with regulatory requirements and industry standards

Benefits:
• Opportunity to work in a dynamic and growing organization
• Competitive compensation and benefits package
• Collaborative and supportive work environment
• Professional development opportunities

Other Information:
• This is a full-time position
• Must be willing to work flexible hours

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