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 DUTIES

• 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

QUALIFICATIONS & REQUIRED 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

Our Recruitment Process: 

To be considered for this role, please apply in our Applicant tracking system and refrain from sending your CV via email. Upon the completion of sourcing (CV collection) period, all received application will be reviewed by our Recruitment experts and evaluated against the needs of the open role. Successful candidates will be contacted by our Recruiting experts for an initial screening interview during which further details about the selection process will be shared. Successful candidates will progress to interviews with line managers, while not selected candidates will be informed in a written form as soon as possible. 
 
Diversity is a fact. Inclusion is an act @Zentiva  
 
At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. 

Join our winning team! Be a part of our winning culture! Be Zentiva!