Quality Assurance Manager - Quality Assurance and Control

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
• Maintenance of the compliance to the BoH Regulations. Accountable for the assessment of new local regulatory requirements. Coordinate the product quality and compliance of authorized activities, to ensure Board of Health (BoH) expectations are met. Responsible for the timely implementation of all applicable procedures.
• Monitor Key Indicators Performance (KPIs), evaluate and highlight any significant trends. Identify actions and track them until completion.
• Support training program implementation for all quality related tasks of the employees involved in the distribution of medicinal products is completed.
• Inspection and Internal Audit: Support preparation and coordination of the GDP / Marketing Authorization Holder (MAH) related regulatory inspections or Pfizer internal audits. Ensure Self-Inspections are performed at appropriate regular intervals.
• Manage planned, permanent and temporary changes of GxP related activities.
• Notification to Management :  Notify Sr Manager/Leaders of significant deviations and any issue impacting marketed product in compliance with applicable procedures.
• Participate in regular Management Quality Review with stakeholders.
• Deviation and CAPA Management & Oversight: Perform the investigation of deviations occurred within the responsibility of the country. Ensure the implementation of the local actions e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions (CAPAs).
• Product Complaint Handling: Ensure that product quality complaints are dealt with effectively.
• Local Product Disposition: Perform local release of incoming finished products, in compliance with the applicable GDP regulations and Pfizer procedures prior to the distribution for sale in the country.
• Oversight of local repackaging/relabelling operations: Ensure relabelling/repackaging contractors have been assessed and approved. Ensure local regulatory authorities’ approval of the repackaging/relabeling activities. Ensure release of repackaged/relabeled product according to GDP and local requirements.
• Responsible for defining requirements under which returns can be reintegrated in saleable stock.
• Services or contractor management: - Oversee Pfizer quality operations at contractors. - Ensure quality agreements are maintained and updated. - Coordinate, support and participate in Audits to vendors. Track CAPA Plan. - Notify Leaders of significant concerns or repeated deviations occurred with contractors and all issues potentially affecting marketed product.

Here Is What You Need

• University degree in pharmaceutical science or other scientific discipline
• Comprehensive knowledge of pharmaceutical legislation, GDP
• Excellent stakeholder and customer service skills
• Strong negotiation and effective communication skills
• “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

  
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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Quality Assurance and Control