QA Investigations Expert - Pfizer
CANDIDATI - Scadenza 1 ottobre
Location: Catania
Mission
To coordinate the activities regarding the management of Production and Laboratory Deviations.
To periodically verify the status of corrective and preventive actions correlated to site Deviations.
Qualifications
Must have:
- Degree in Chemistry/Industrial Chemistry, PCT (Pharmaceutical Chemistry and Technology).
- Knowledge of the English language both written and spoken
Nice to have
- Good knowledge of production activities and processes and of corporate Quality management.
- Knowledge of Good Manufacturing Practices and corporate procedures.
- Six sigma certification qualification
- PHP knowledge
- Previous experience in a similar role is a plus.
Tipologia contrattuale:
Assunzione con contratto di lavoro la cui tipologia sarà stabilita durante il processo di selezione
CCNL Chimico-Farmaceutico
Organizational context:
Hierarchically the function reports to the QA Investigations Sr. Supervisor;
The function operates in accordance with company procedures for the management of Production Deviations (MIR) and Laboratory Non-Compliances (LIR), of Commitments.
In the framework of these activities, has contacts with the Responsible people of Manufacturing various Departments/Offices (Production, Quality, Engineering, IT, etc.), with the Suppliers for investigation requests originated from Non-Compliances on materials issued by Production Departments and by Quality Control Laboratory.
Main Responsibilities
- To perform a first assessment of MIRs and LIRs, to coordinate investigations, on indication of the Direct Superior, making sure to finish them within the established time limit and, when necessary;
- To promote meetings with the Responsible people of the involved Departments;
- To use the computer systems for the management of MIRs/LIRs and related commitments;
- To identify the GMP aspects relevant to Deviations and, based on what is observed;
- To opportunely address the corrective actions notifying them to the Direct Superior;
- To manage the Commitments originated from MIRs/LIRs;
- To take part in the writing of the Product Quality Review (PQR) for the sections relative to the Investigations group;
- To prepare the monthly report of metrics as regards the expected MIR, LIR and First Time Quality (FTQ) parameters;
- To submit the investigations and the conclusive reports on MIR and LIR to the superior function and to cure their formal closure and subsequent archiving;
- To collaborate, at the request of the Direct Superior, with the Manufacturing Departments to identify the best approach, under the GMP point of view, to the various problems and to provide, when requested, the most correct interpretation of Good Manufacturing Practices and of company procedures;
- To follow the requirements of workplace safety system and to take part to EHS training.
In tutto il mondo, i colleghi Pfizer lavorano insieme per avere un impatto positivo sulla salute di tutti, a livello globale. I nostri colleghi hanno l'opportunità di crescere e intraprendere una carriera che porti al successo personale e aziendale; far parte di una cultura che valorizza la diversità e in cui tutti sono altamente motivati e coinvolti; senza dimenticare l'impatto concreto sulla salute e la vita di milioni di persone. Pfizer, leader mondiale nell'industria biofarmaceutica, è alla continua ricerca di talenti, ispirati dal nostro obiettivo principale: garantire terapie innovative che migliorino la vita dei pazienti in modo significativo.