Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Role Summary
Reporting to the Production Compliance Manager, this role will provide support to the Production Team ensuring efficient management of system documentation, product quality investigations, and GMP compliance.
Primary Responsibilities
* Provides support, information, and assistance with the initiation, investigation, submission, and closure of the following documents:
* Operational Events
* Management of Change
* TERs
* Operational Deviations
* Customer Complaints
* Verify the effectiveness of corrective/preventive actions based on root cause analysis.
* Through verification of corrective/preventive actions, identify opportunities for continuous improvement across similar processes and procedures.
* Assist the Continuous Improvement function to complete root cause investigations into internal packaging department delays.
* Facilitate reviews of and revise department-related documents (i.e., SOPs and Logbooks etc).
* Represent the Packaging function in NPI/MOC projects to ensure necessary documentation is completed, reviewed, and communicated as required.
* Develop, implement, and report appropriate KPIs relating to the role.
* Undertake such tasks and manage specific or ad-hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
Requirements
* Minimum 2 years of working with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, or related experience.
* 3rd Level qualification in a Science/Engineering subject preferred but not essential if relevant experience can be demonstrated working in a Quality or Compliance job role.
* Succesfully demonstrate use of root cause analysis/corrective & preventive action methods.
* Excellent analytical and critical thinking skills with a record of successfully implementing change management.
* Maintains knowledge of current Good Manufacturing Practices.
* Excellent communication skills, both verbal and written.
You are a key player in building the bridge between life-changing therapies and patients.