Functieomschrijving
Location/Division Specific Information
The pharmaceutical manufacturing plant in Ferentino (80km from Rome), with more than 850 employees, is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized formulations, with an increasing focus on biologics
Responsabilità
HoH
What will you do?
- Ensure the execution of validation activities for CSV projects according to the timeline, procedures and the priorities defined by the company
- Lead cross functional team and external personnel on assigned projects as defined within the Proactive Quality plan
- Draft the main validation documents (URS, plans, risk analysis, test protocols and reports) in accordance with the internal procedures, collaborating with other departments and external consultants
- Ensure that the validation documentation produced or issued by suppliers complies with internal quality standards.
- Ensure the regular planning and implementation of CSV training.
- Provide training for external personnel involved in validation activities.
- Ensure the continuous update of CSV procedures according to the internal, industry and regulatory trend.
- Support the management of external personnel involved in validation activities
- Administrators Audit Trail Review
- Computer System/SAP access periodic review
- Management of any related non-conformity emerged during the Audit Trail/periodic review
- Support on the resolution of any anomalies emerged Computer Systems
- Support on the management of deviations involving Computer Systems.
- Participation during customer and regulatory inspections
- Support for Proactive Quality/Data Integrity initiatives
Functie-eisen
How will you get here?
Education
Degree pharma, chemical, engineering on computer science
Experience
- Minimum 2 year computer system validation experience
- Pharma/Manufacturing experience
Knowledge, Skills, Abilities
- Knowledge of GMPs, Data Integrity, GAMPs and CFR part 11 regulations;
- Strong interpersonal skills with proven ability to build and maintain relationships, teambuilding, adaptability, excellent problem solving & communication skills
- Fluent in Italian and English
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
