Description
Use Your Power for Purpose
Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that every step we take is aligned with our mission to improve patient outcomes. Join us in our mission to make a difference in the lives of patients through your expertise and dedication.
What You Will Achieve
In this role, you will:
- Lead and provide guidance on moderately complex projects, managing time effectively to meet objectives.
- Apply skills and knowledge to contribute to departmental work and make decisions to resolve moderately complex problems.
- Operate independently in ambiguous situations, developing new options guided by policies in non-standard scenarios.
- Maintain compliance with Board of Health (BoH) Regulations, assess new local regulatory requirements, and coordinate product quality and compliance of authorized activities.
- Monitor Key Performance Indicators (KPIs), evaluate and highlight significant trends, identify actions, and track them until completion.
- Support training program implementation for all quality-related tasks of employees involved in the distribution of medicinal products.
- Support preparation and coordination of GDP/Marketing Authorization Holder (MAH) related regulatory inspections or Pfizer internal audits.
- Manage planned, permanent, and temporary changes of GxP-related activities.
- Notify Senior Managers/Leaders of significant deviations and any issues impacting marketed products.
- Participate in regular Management Quality Review with stakeholders.
- Perform investigations of deviations, implement local actions, and ensure compliance with applicable procedures.
- Ensure effective handling of product quality complaints.
- Perform local release of incoming finished products in compliance with applicable GDP regulations and Pfizer procedures.
- Oversee local repackaging/relabelling operations, ensuring contractors are assessed and approved.
- Define requirements under which returns can be reintegrated into saleable stock.
- Oversee Pfizer quality operations at contractors, maintain and update quality agreements, and coordinate audits.
Here Is What You Need
- University degree in pharmaceutical science or other scientific discipline.
- Comprehensive knowledge of pharmaceutical legislation and GDP.
- Excellent stakeholder and customer service skills.
- Strong negotiation and effective communication skills.
- A 'can-do' attitude with a passion for innovation.
- Experience with SAP.
- Ability to manage and lead projects independently.
- Strong analytical and problem-solving skills.
- Fluency (both written and verbal) in Slovenian and English.