Manufacturing Investigator

2 weeks ago

Tullamore, Uíbh Fhailí, Ireland Zoetis Full time

POSITION SUMMARY

The Manufacturing Investigator is a key team member within the Manufacturing Department. The Manufacturing Investigator uses expert knowledge of compliance and GXP manufacturing processes to lead staff and demonstrate best practices in the management of investigations and improvement initiatives within manufacturing operations. This role will include responsibility for the successful completion of deviations, as well as the identification and implementation of corrective/preventative actions, within their organization. This individual is responsible for maintaining deviation timelines and escalating when they cannot be met, as well as mentoring others on cGMP expectations. The individual must demonstrate an in-depth understanding of their areas' processes and procedures, as well as cGDPs and cGMPs, and applies them to investigation and documentation of deviation root cause and compliance impact. The individual will be responsible for analysing performance metrics and identifying trends and implementing actions to improve performance and compliance in their area.

POSITION RESPONSIBILITIES

  • Gathering data from various sources across the site, performance of Root Cause Analysis (RCA) using tools such as fishbone diagrams, "5 Whys", Process mapping to determine the most likely cause, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments such as FMEA's.
  • Technical writing, translating very complex and challenging scientific events into a brief and cohesive report as a finished product.
  • Work on the manufacturing floor for data gathering and observing of processes for investigations.
  • Apply Site and Global compliance SOPs to investigations.
  • Provide technical input and support writing of technical reports required for regulatory purposes.
  • Participate in Quality and Safety regulatory audits.

ORGANIZATIONAL RELATIONSHIPS

This role will include working with teams, both in Zoetis Tullamore and externally with Contract Manufacturing Organisations. The role will involve interaction with USP, and DSP within the manufacturing department and with external stakeholders such as QC, WHSE and ENG. The role will require strong interaction with QA.

EDUCATION AND EXPERIENCE

  • BSc, MSc, PhD in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience.
  • 2-5 years' relevant experience in bioprocess development and/or manufacturing.
  • Knowledge of Cell culture and protein purification.
  • Working in a controlled regulated environment e.g. GMP/GLP.
  • Experience working with external contractors.
  • Excellent project management capability.
  • Excellent verbal and written communication skills. Ability to maintain very clear records of work completed.
  • Ability to work effectively as part of a team across all departments in Zoetis Tullamore.

TECHNICAL SKILLS REQUIREMENTS

  • Be proficient in ETS, SAP, Veeva Vault, strong knowledge of Excel, Word, and PowerPoint desirable.
  • Ability to work in a cross-functional team environment.
  • Applies knowledge and subject matter expertise to ensure end-to-end of investigations.
  • Anticipates and prevents potential issues with regulators.
  • Own and/or Drive Improvement projects/initiatives.
  • Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.

PHYSICAL POSITION REQUIREMENTS

This will primarily be desk-based. There will be a requirement to support out of hours activities on occasion.

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