Quality Oversight Specialist For Production

9 ore fa

Brindisi, Italia Euroapi A tempo pieno

Join Quality team of Brindisi site to work on GMP tasks "on the shop floor". you will promote culture and respect of cGMP in production departments and you will identify and implement in close collaboration with the production departments actions to improve and simplify activities, always in full compliance with GMP requirements, regulatory and business requirements.
- Your Responsibilities- Verification of the completion of departmental documentation: logbooks, annexes procedures, laboratory records, documentation used by the warehouse, packaging and technical services department, BPR and checklists related to the production stage observed during the oversight
- Identification of non-compliance, suspected non-compliance, improvements and best practices of GxP activities on the shopfloor coaching to personnel directly involved in GxP activities
- Identification of gaps in documentation and bringing them to the attention of quality assurance and the department supervisors involved, so that documents can be reviewed
- Verification that any deviations is correctly reported in batch records Highlight of behavioral issues, to clearly convey acceptable and unacceptable behaviors, and to understand people's point of view
- Verification of proper cleaning, maintenance and housekeeping of the areas Examination of documents: registration Dossier, Process Validation reports, MBPR and Analytical specifications, Batch records of released batches including analytical data, deviation trends, complaints, stability data and analytical data
- Interaction with the Phenix system according to own profile (e.g. Event Creator, Investigation leader, QA Expert, CAPA implementation leader, Efficiency Reviews responsible etc.)
- Investigations of production quality concerns (Deviations, OOS and OOT) and related reports Implementation of own improvement action plans (CAPAs)
- Periodical reporting of own key quality indicators Involvement in change control activities (works) as needed Definition, review of SOP's and training to concerned people Internal audit support; direct participation in Health Authorities (AIFA, FDA, etc.) inspections and customer audits.
- Our Company- EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers' and patients' needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.- The EUROAPI Italy facility is a vast production site with over 240 workers located in the industrial area of Brindisi with a history dating back to 1966. EUROAPI Italy is specialized in the development and manufacturing of Active Pharmaceutical Ingredients (APIs), including antibiotics, corticosteroids and other intermediates by large scale fermentation under GMP conditions.- Our Requirements- Previous experience in GMP environment, quality, quality control or manufacturing
Good knowledge of GMP principles
Ability to recognize and manage problems
Accurate and meaningful reporting capability
Good knowledge of English
Good communication skills that allow direct interaction with operators, technicians involved in the relevant GMP process/system.- Your Benefits- Competitive Salary
- Annual Bonus
- Company cantine
- Training & Development
- Culture & Values at EUROAPI- We bring our culture to life in the way we work every day. Our culture enables career development and talent management, we recognize that how we do things is as important as what we do, and our values set out how we achieve our goals and help us "do it right".- Diversity & Inclusion- EUROAPI is committed to nurturing a culture of diversity and inclusion that contributes to improving innovation, performance, and engagement. We value transparency, mutual respect, and equal treatment of people. For this reason, we are firm in protecting our employees against any forms of discrimination.- Environment, Social and Governance- We strongly believe that the success of our company lies in its capacity to adapt to tomorrow's challenges. Our responsibility as a company is to provide sustainability and resilience to the pharmaceutical value chain.

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