Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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:
1. Provides support, information and assistance with the initiation, investigation, submission and closure of the following documents:
Operational Events
Management of Change
TER’s
Operational Deviations
Customer Complaints
2. Verify the effectiveness of corrective / preventive actions based on root cause analysis.
3. Through verification corrective / preventive actions identify opportunities for continuous improvement across similar processes and procedures.
4. Assist the Continuous Improvement function to complete root cause investigations into internal packaging department delays.
5. Facilitate reviews of and revise department related documents i.e., SOP's and Logbooks etc
6. Represent the Packaging function in NPI / MOC projects to ensure the necessary documentation is completed, reviewed and communicated as required.
7. Develop, implement and report appropriate KPI’s relating to the role.
8. To undertake such tasks and to 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:
1. Minimum 2 years of working with quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs, or related experience.
2. 3rd Level qualification in a Science/Engineering subject preferred but is not essential if relevant experience can be demonstrated working in a Quality or Compliance job role.
3. Successfully demonstrate use of root cause analysis / corrective & preventive action methods.
4. Excellent analytical and critical thinking skills with a record of successfully implementing change management.
5. Maintains knowledge of current Good Manufacturing Practices.
6. Excellent communication skills, both verbal and written.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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