Validation Manager
Azienda:
Human Value

Our Client

Our Client is Pfizer, one of the most prestigious multinational company in the pharmaceutical market. We are supporting one of the sites, located in Catania, supplying sterile FDA approved products through Aseptic Manufacturing, Lyophilisation and packaging activities. We are seeking for the Validation Manager
 

The Role

Reporting to the Quality Director, the positions leads a team of colleagues with a wide range of validation and compliance responsibilities. These responsibilities include but not limited to:

  • Equipment and Process Validation: this uniti s responsible for the overall validation organization and all aspects of validation for equipment process and products at the site.
  • Tech Transfer: consisting of a manager and a team of professionals who support every product and transfer project at the site. These projects arise from many separate processes, including continuous improvement projects, and business. The incumbent will develop close communication channels with each of these various project sources.
  • Audits and Inspections: a unit assuring that compliance validation and data integrity requirements are met. Provides necessary advice and expertise during audit and inspection
  • Product and Process Validation: includes a manager and a team of professionals who support all product and process validation at the site while following industry contemporary and Pfizer Quality Standards.
  • Site Change Management Program - a team of professionals that are responsible for keeping the validated status of finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.
  • Cleaning Validation - consists of a manager and a team of professionals to ensure that all cleaning processes are qualified, and that products process of being enhanced are validated appropriately.

The successful candidate is responsible for:

  • providing strategic and tactical support to the managers and professionals in all of the mentioned areas
  • assuring the development, mentoring, and performance management of the team.
  • The candidate will also maintain appropriate contacts to access additional information in regards to the Implementing resource projections and budget preparations
  • Providing or overseeing the preparation of project cost estimates.

Requirements

  • BS/MS or PhD in Chemistry, Biochemistry, Engineering, Pharmacy or related science
  • At least 10 years in the Pharma industry and minimum 5 years of direct experience in validation.
  • The candidate should have experience in at least several of the following: GMP, Regulatory (world wide), deviation investigation, technical product transfers, and product and process validation.
  • Experience in sterile injectables manufacturing is preferred
  • Previous experience as a manager of colleagues is required and experience leading first line supervisors is preferred.
  • The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
  • The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.
  • To perform this job successfully, an individual should have an advanced knowledge of MicroSoft Office (Word, Excel, Outlook, Access, and Projects)
Azioni Annuncio
Altri Annunci

  Altri annunci di questa azienda
 
Dettagli annuncio
DATA DI PUBBLICAZIONE
07/10/2019
LUOGO
Sicilia/Catania

SETTORE
Chimico, farmaceutico

CATEGORIA - RUOLO
Direzione Generale e Management/Manager; Produzione/Responsabile qualità

ANNI DI ESPERIENZA
oltre 10 anni

CONTRATTO
Tempo indeterminato

Questo sito utilizza cookie tecnici, cookies di profilazione e cookies di terze parti per la gestione della navigazione. Se vuoi saperne di più clicca qui. Se accedi a qualunque elemento del presente sito, esterno a questo banner, acconsenti all'uso dei cookie.