Quality Assurance Operations Manager

POSITION PURPOSE

The Quality Operations Manager is responsible to assure the GxP compliance of the quality processes on operational manufacturing activities at the site to ensure products are manufactured according to established quality standards. The Quality Operations Manager ensure the quality compliance of the activities and of the product throughout their life cycle.

KEY RESPONSIBILITIES AND ACTIVITIES

· Responsible quality representative and the main point of contact for quality topics related to production activities and products

· Lead the QA Operations Team promoting a quality culture in line with Zentiva values

· Assure production operations are executed in compliance with GxP, internal procedures and guidelines and provide expertise to support the resolution of issues

· Work with different stakeholders to ensure business needs are met in a compliant manner

· Support investigation process to ensure the timely evaluation of deviation and complaints and their escalation when needed

· Review and approve risk assessments, change controls, deviation and compliant investigations and their associated CAPAs

· Edit, review, approve GMP documents and internal procedures

· Oversee the coordination and the completion Product Quality Reviews

· Appropriate and timely reporting of KPIs

· Support internal, external , customers audits and assist during Health Authority Inspections as required

· The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

· University degree in Pharmacy, Chemistry, Biology, or relevant Life Science

· Minimum of 5 years of relevant experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a managerial position

· Proven cross-functional project management skills

· Strong knowledge of GMP processes and regulations, pharmaceutical quality assurance principles and regulatory requirements

· Excellent analytical problem solving skills

· Leadership and team management capabilities

· Flexibility and ability to manage competing priorities

· Effective communication and negotiation skills

· Collaborative, team-spirited, positive, and energetic person

· Fluent in English