Job Summary
Job focuses on delivering process and qualification studies for Drug Product (DP) manufacturing process, Quality Control equipment and Warehouse (Dispensing), in compliance with current Good Manufacturing Practices (cGMPs) and all other applicable regulations.
Functions and responsibilities:
- Elaborate SOPs related to Parenterals Technical Services and maintain all documentation updated.
- Give support to previous qualification stages (URS elaboration, IP/OQ/verification)
- Elaborate protocols for equipment performance qualification, execute validation studies in partnership with Operations Departments and prepare validation reports.
- Execute equipment and clean rooms re-qualification following an established frequency.
- Manage and maintain Aseptic Process Simulation (APS) Interventions Program in collaboration with impacted departments.
- Elaborate protocols for process and cleaning validation, execute validation studies in partnership with Operations Departments and prepare validation reports.
- Manage and maintain Cleaning Monitoring Program in collaboration with impacted departments.
- Identify Critical Process Parameters for process, equipment, and systems.
- Elaborate and maintain Continuous Process Verification (CPV) plan for each product, analyse data and trends, lead periodic meetings involving impacted departments and prepare reports.
- Perform Annual Product Quality Review (APQR) for each product, analyse data and trends and prepare section of manufacturing and cleaning validation process.
- Complete projects and commitments on schedule.
- Supports troubleshooting and resolution of process deviations. Performs root-cause analysis and identifies appropriate, effective corrective and preventive actions.
- Elaborate Process and Product Impact Assessments (for deviations, quality risk analysis and change control)
- Troubleshooting of DP manufacturing operations, collaborating to resolve process and technical issues. Perform Process Risk Assessments and implement controls to decrease risks detected.
- Lead Quality risk assessments
- Manage major changes to manufacturing process through site Change Control system
- Evaluate new Active Ingredients/API, raw materials and primary packaging components including from a MDCP perspective.
- Support Compliance Inspections and enquiries from regulatory agencies
- Participate in cross-functional project teams as applicable to enable equipment design, installation and qualification, technology transfer and new product introductions.
- Lead to continuous improvement of current operations to improve process robustness, quality and/or productivity.
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Minimum training and education requirements:
Bachelor's Degree (or above) in Pharmacy, Chemistry, Engineering or other Life Sciences degree.
Experience required
- At least two years of experience in the pharmaceutical industry in the areas of Parenterals product/process development, validation or manufacturing.
- Demonstrated ability to provide technical solutions for complex problems through product and process knowledge
- Demonstrated ability to lead change and strong collaborative skills
#LI-PFE
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Se valorarán las candidaturas que puedan aportar certificados oficiales de discapacidad.
The only available locations for new employees are Madrid or Barcelona
Manufacturing