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.
Position Overview
* enable timely and accurate review/disposition of material/product records and physical checks to GMP and Client/Sponsor requirements
* support 'Quality On the Floor' for prompt issue resolution and quality oversight of GMP activities
* work closely with key stake holders (including but not limited to) Warehouse, Production, Project Managers, at PCI-MEL and within the PCI Network.
Primary Responsibilities Include
* Non-laboratory based receipt, testing and disposition of incoming materials/products for use in Production or Distribution
* Creation and review of materials/product specifications
* Issue and archive documentation pertaining to incoming/dispatch material/product records, packaging test records and specifications
* Support the assessment of returned materials/products and the required documentation for disposition
* Update inventory management system for dispositioned materials/products and products intended for destruction
* Perform Pre-Dispatch checks according to PCI procedures to ensure products have been correctly picked, prepared and shipped according to Client/Sponsor orders
* Support the ongoing management of retention samples
* Review Warehouse documentation and logs to ensure compliance with Good Documentation Practices
* Complete, review and support site investigations/escalations for the determination of root cause/impact/risk for EVENTs, Deviations, Complaints, Non-Conformance and change controls
* Support the completion of internal, client and regulatory inspections, including the response to findings and completion of corrective and preventative actions
* Support applications and management of import / export permits
* Create and review operational SOPs/WI/Forms (as required)
* Support mock recall and recall activities instigated by PCI or clients
* Action continuous improvements to enhance Quality Operations performance, compliance to regulatory requirements and improvements in site Standard Operating Procedures (SOPs)
* Report metrics related to Incoming Release and assist with the preparation of Quality Management Review information
* Support the completion of other Quality Operations team responsibilities as required (e.g., Product/Material Inspections, product specification file creation etc)
* Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
Qualifications, Experience & Behavioural Competencies
* Bachelor of Science, Pharmacy or related Discipline
* Experience in cGMP pharmaceutical environment
* Proficient user of Microsoft Word and Excel
* Experience in a Quality role within a pharmaceutical company, e.g, Scientific background
* Use of quality management system and inventory management system software in a regulated industry
Specific Behavioural Competencies Required
* Compliance and adherence to GMP and PCI procedures and policies
* Competent in written and verbal skills, with excellent attention to detail
* Ability to work in fast-paced, dynamic environment
* Communication and responsiveness at all the times
* Positive, 'can-do' attitude, embraces and 'lives' PCI's Vision and Values
* Analytical thinker and solution finder/problem solver
* Collaborative, team player
* Trusting and trustworthy
* Conscientious and diligentPositive, embraces and is responsive to change
* Flexible with managing workload and changing priorities
* Effective time management
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.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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