PCI is your world leading CDMO, providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market and opportunities for commercial success.
PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of CDMO services.
With 30 sites across Australia, Canada, North America, the UK, and Europe and over 6000+ dedicated employees, together, delivering life changing therapies.
Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.

PCI Pharma Services

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general

PCI Pharma Services is a leading Contract Development and Manufacturing Organization (CDMO) specializing in the pharmaceutical sector. They offer a range of services including advanced drug delivery and drug device combination products, clinical trial services, and commercial packaging. With over 20 years of experience in sterile development and manufacturing, PCI Pharma Services focuses on delivering life-changing therapies through innovation and patient-centric design. Their extensive expertise enables them to manage a diverse portfolio of biopharmaceutical therapies and personalized medicines from development through to commercialization. The company operates globally, supporting clients with GMP facilities across North America, Europe, and Asia Pacific.

PCI is your world leading CDMO, providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of CDMO services. With 30 sites across Australia, Canada, North America, the UK, and Europe and over 6000+ dedicated employees, together, delivering life changing therapies. Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.

• Own overall validation projects for high-risk projects under limited to no supervision
• Generate and execute validation protocols
• Assist with audits and determine validation needs
• Train Analysts
• Perform validation activities to ensure compliance with government and customer requirements
• Prepare validation protocols, statements, reports, summaries, and master validation plans for new customer, product, and system launches
• Maintain validated processes and programs at multiple sites
• Organize and coordinate internal and customer approvals
• Ensure validation documentation completion, accuracy, and closure
• Prepare change controls and validation history reports for audits
• Attend conference calls and meetings
• Communicate project goals and progress to the Validation Supervisor/Manager
• Investigate validation deviations, document formal reports, and ensure corrective-action resolution
• Serve as primary contact for quality validation activities and manage expectations
• Review and interpret standards, procedures, and specifications for validation protocols
• Specialize in one or more validation areas: Process/Cleaning, HVAC/Utility, or Computer Validation

Validation Specialist

Validation Specialist managing high-risk validation projects for PCI Pharma Services, a biopharma services company. Preparing protocols, audit documentation, and compliance reports across specialized validation areas.

business-development-rep

• Assist Business Development Executives with daily account management
• Prepare for and manage Quarterly Business Review Meetings
• Take and provide comprehensive meeting notes during client meetings
• Directly manage smaller client accounts
• Identify global drug development targets and research development pipelines
• Identify appropriate contacts and support cold calls, mailers, and geography-specific marketing campaigns
• Research drug development companies and update information in Salesforce.com
• Make outbound calls to drug development companies, including CROs, medical device, animal health, and cell and gene therapy organizations
• Attend client meetings and generate comprehensive meeting minutes within two days
• Follow up on client and Global BD team information requests
• Respond to inquiries received by email, website, phone, and trade shows
• Attend trade shows in a supportive capacity when required
• Manage PCI site visits, including booking rooms, organizing attendees, and collating presentation materials
• Attend PCI site meetings on behalf of Business Development Executives when appropriate
• Support and manage submission of legal documentation such as CDAs and MSAs

Associate Clinical Business Development Executive

Associate Business Development Executive supporting PCI Pharma Services’ clinical services growth through lead generation, account management, and client meetings. Conducting drug-development research and supporting global business development teams.

qa-engineer

• Responsible for the Supervision of the QA associates, ensuring that all site licenses are kept up to date
• Hosting external client audits
• Manages the KPIs and Metrics reporting to site management and Corporate
• Works closely with site management, production, and customer service to ensure customer requirements and timelines are met and comply with internal operating standards and regulatory standards (cGMPs/GMPs)
• Supervises the QA Associates
• Provides direction on dealing with issues during production and elevates issues to Sr. Director Quality Operations and site management as required
• Reviews and approves executed inspection and production related documentation
• Conducts training on PCI's Quality Management Systems, processes and performs annual GMP refresher training
• Initiates CAPA’s resulting from deviations, customer complaints, identified non-conformance, audits, or any other means of problem identification

Compliance and QA Inspector Supervisor

Supervising QA associates in PCI Pharma Services ensuring compliance with regulatory standards and effective quality management. Managing external audits and collaborating with production and customer service teams.

PCI Pharma Services

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3 jobs found

Validation Specialist

PCI Pharma Services

Associate Clinical Business Development Executive

PCI Pharma Services

Compliance and QA Inspector Supervisor

PCI Pharma Services