PQA Support
The position
For our site in Fornovo San Giovanni we are looking for a candidate to join the Quality Assurance Department within a company that produces Active Pharmaceutical Ingredients (APIs) destined to the manufacturing of drugs for Human Pharma and Animal Health.
Responsibilities:
- Follow the investigation activities relating to discrepancies, product non-conformities, returns, complaints and recalls, prepare summary reports and follow the progress of any defined actions; ensures that local discrepancies and CAPAs are closed in a timely manner.
- Evaluate changes (Change Control management), including the issuance of the related documentation and the verification of the progress of the defined actions.
- Collaborate for the validation of production processes in the industrial phase, reworking, reprocessing, cleaning of production plants and computerized systems.
- Follow the activities of collection, verification and storage of the production, quality control, packaging and repackaging documentation of each batch manufactured.
- Follow the collection and evaluation of the process and analytical data necessary for the annual review of the quality of the products, and ensure the timely issuance of the related reports.
- Collaborate in the evaluation of production processes and the identification of opportunities for improvement.
- Participate to internal and external audits, and support in the CAPA plan.
- Collaborate in the preparation and issuance of the Standard Operating Procedures (SOPs) of Product function.
- Participate in information and training programs planned for the QA function.
Requirements:
- Previous experience in a similar role within Quality Assurance departments (around 1 year)
- Knowledge of GMP standards, basic knowledge of the local and international legal/regulatory requirements
- Languages: Fluent Italian and good knowledge of English (level B2)
- Good knowledge of Ms Office (especially Excel and PowerPoint)
- Curious and analytical attitude, propensity for continuous improvement, innovation and teamwork
- Degree in Scientific disciplines
What we offer:
- For this position we offer a temporary contract with an external agency – 12 months;
- Free access to the company canteen;
- A range of benefits for you physical, financial, social and mental wellbeing (access to gyms, psychologist, volunteering, parental benefits and more);
- A support to develop your own professional and personal path that will guide you through our full range of development programs including platforms to learn foreign languages and attend professional courses.
In Boehringer Ingelheim we are committed to guarantee equal opportunities; we believe in respect, trust and empathy, in a work environment without discrimination.
We are powered by our people as we know that our differences are our strengths. We value everyone and each of us feels included, important and at ease.
This job requisition is addressed also for candidates with disabilities and belonging to protect categories following articles 1 and 18, Law 68/99.