Manufacturing Process Development Manager

2 weeks ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

We are seeking a highly skilled Manufacturing Process Development Manager to join our team at PharmaRelations ApS. As a key member of our organization, you will play a vital role in the development, optimization, and validation of manufacturing processes for Nordberg Medical's implantable Class III medical devices.

Responsibilities:
  • Process Development and Optimization:
  1. Develop and optimize manufacturing processes for new and existing implantable medical device (Class III) products.
  2. Collaborate with manufacturing teams and alliance partners to implement efficient, scalable, and compliant production processes.
  3. Develop and maintain process workflows, control plans, and standard operating procedures (SOPs).
  • Process Validation and Qualification:
  1. Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification), for new and modified manufacturing processes.
  2. Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements.
  3. Analyze and document validation results, addressing any deviations or non-conformances.
  4. Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.
  • Continuous Improvement and Optimization:
  1. Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
  2. Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.
  3. Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Production, to align on process requirements and project timelines.
  4. Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.
  5. Collect and analyze production data to monitor process performance and identify areas for improvement.
  6. Generate reports, metrics, and presentations for management, summarizing process performance, validation activities, and improvement initiatives.


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