Process Support Specialist Co. Carlow

1 week ago

Pittsburgh, Pennsylvania, United States Pro Chem Inc. Full time
Job Title: Process Support Specialist Co. Carlow

Job Summary:

This is an exciting opportunity for a Process Support Specialist to join our team at Pro Chem Inc. in Co. Carlow. As a Process Support Specialist, you will be responsible for generating and expediting review and approval processes for IPT GMP documentation, including Quality Notifications, CAPA close out records, IPT Standard Operating Procedures, and Standard Work Instructions and change controls.

Key Responsibilities:

  • Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
  • Be a document system expert; this will include document review, approval and document system workflow expedition.
  • Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases.
  • Raise CAPAs and conduct investigations.
  • Complete Customer complaint investigations and Change Controls.
  • Required to comply with site Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities.
  • Work collaboratively to drive a safe and compliant culture on site.

Requirements:

  • Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • SAP knowledge and experience required.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Lean Six Sigma Methodology experience desired.
  • Focus on Customers and Patients.
  • Risk management skills, Strategy planning and development.
  • Demonstrable analytical and systematic problem-solving skills.
  • Effective time management and multi-tasking skills.
  • Proven organizational and Trouble shooting skills.
  • Excellent attention to detail.
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • Understand the specific responsibilities of all site departments as they relate to ones own department, understanding the business processes ones department supports.
  • Strong team skills, including ability to coach/develop work teams.
  • Excellent training, facilitation and assessment skills.

How to Apply:

If you are a motivated and detail-oriented individual with a passion for process improvement and regulatory compliance, we encourage you to apply for this exciting opportunity.

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