In this challenging role, you will be responsible for Quality Control on our site in Lisbon. In this function, you directly report to the Head of Quality Management. Your role is to manage human and technical resources to ensure product QC disposition meeting quality compliance with lead-time and cost control optimization.
Your responsibilities include:
Manage and Coordinate the Quality Control team and processes
To approve or reject, as appropriate, starting materials, packaging materials, intermediate, bulk and finished products;
To ensure that all necessary testing is carried out and the associated records evaluated;
To approve specifications, sampling instructions, test methods and other Quality Control procedures;
To approve and monitor any contract analysis or service;
To ensure the qualification and maintenance of his department, premises and equipment;
To ensure that the appropriate validations and/or transfers are done;
To ensure that the required initial and continuing training of the department personnel is carried out and adapted according to need;
To ensure that a suitable stability program is in place;
To assure that a reference and retention samples are properly archived;
To assure QC proper collaboration in site or corporate projects
Contribute, as applicable to the design, effective implementation, monitoring and maintenance of the quality management system
Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement
Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Coordinate QC team and activities assuring the best performance both in routine processes and project related activities;
Assure QC and related activities are in compliance with Good Manufacturing Practices;
Assure financial control and resources assessment;
Assure effective communication between stakeholders;
Assure compliance with the Operational Excellence Roadmap;
Develop the respective activities in order to contribute to the continuous improvement of the company's performance in terms of Quality, Environment and Safety;
Participate in the maintenance of the Quality and Environment Management systems implemented and comply with the legislation applicable to the respective activities;
For this role, we are looking for a reliable and dynamic person with the following profile:
Master’s degree in related Life Sciences discipline (pharmaceutical industry, biotechnology, chemistry) or pharmacist
Minimum 5 years’ experience in a management function within the pharmaceutical industry, within Quality Control Department
Previous experience in Quality Assurance would be advantageous
Relevant experience in Pharmaceutical Industry and GMP environment;
Solid experience with FDA (Food and Drug Administration) is mandatory
Fluent in English and Portuguese (written and verbally)
You have entrepreneurial spirit. You like to coach people to achieve their best performance. Your ability to communicate with different stakeholders and your high level of flexibility help you to examine and understand issues from multiple perspectives or points of view. Additionally, your planning, organization, time management and prioritization skills will support our organization in anticipating planning issues and supporting the team to find solutions.
Vifor Pharma Group is a global pharmaceuticals company. It holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).