The ESO Quality Senior Specialist is responsible for the full quality lifecycle management of an assigned product portfolio and independent Quality Assurance oversight of external suppliers.
The role leads complex quality topics, identifies and manages quality risks, drives improvements within the Quality Management System, and acts as a senior Quality expert for internal and external stakeholders.
MAIN ACCOUNTABILITIES AND DUTIES
- Manage Quality oversight of assigned products, external manufacturers and suppliers.
- Lead complex deviations, complaints, Root Cause Analysis and CAPA effectiveness reviews.
- Assess and manage change controls and significant quality risks.
- Review manufacturing, analytical, stability and Product Quality Review documentation and identify trends or systemic issues.
- Support batch disposition decisions by evaluating complex Quality risks.
- Lead supplier quality assessments, Quality Agreements and improvement activities.
- Lead and participate in supplier audits and inspection readiness activities.
- Review qualification and validation documentation and challenge strategies and risk assessments where required.
- Ensure compliance with GMP, GDP, ICH and applicable regulatory requirements.
- Identify Data Integrity risks and drive appropriate corrective actions.
- Perform Quality trend analysis, monitor KPIs and drive continuous improvement.
- Provide Quality support for product launches, transfers and lifecycle activities.
- Lead complex Quality discussions, negotiations and escalations with suppliers and stakeholders.
- Act as Subject Matter Expert, provide guidance to colleagues and support capability development within the team.
REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS
- University degree in Pharmacy, Chemistry, Biology or relevant Life Science.
- Minimum 6 years of relevant experience in Quality Assurance or a GMP-regulated pharmaceutical environment.
- Experience and knowledge in sterile manufacturing at plant level is preferred.
- Strong knowledge of GMP, ICH and pharmaceutical regulatory requirements.
- Strong experience with deviations, CAPA, Root Cause Analysis, change control and Quality Risk Management.
- Experience in supplier quality management, audits and external manufacturing is preferred.
- Ability to interpret complex Quality data, identify trends and drive improvements.
- Strong communication, influencing and negotiation skills.
- Ability to manage complex discussions and escalations independently.
- High level of autonomy, accountability and sound Quality judgement.
- Strong analytical and problem-solving skills.
- Proactive, collaborative and solution-oriented approach.
- Ability to coach others and act as Subject Matter Expert.
- English: Advanced level.
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.
