Compliance & Quality System Manager

Azienda

Importante Multinazionale farmaceutica

Descrizione

We are currently looking for a Compliance & Quality System Manager for an important Pharmaceutical Company based in Lombardy near Milan.

Mission of the role:

Lead the sitès Quality Systems and Compliance team in establishing and maintaining quality at the department in accordance with Site SOP's, regulatory guidelines and cGXP compliance requirements.

Maintain high standards of quality at the department through managing and continuously improving the effectiveness of the department quality processes and systems.

Consistently measure, monitor and report site quality key performance indicators

Identify, develop, and retain qualified people to implement the quality processes. Run an efficient and effective Quality Systems organization through managing the department site budget and resources.

Build a team that has the technical expertise, personal skills and interpersonal skills needed to influence site Operations and is conversant in application of regulations

Foster and develop on site Quality Culture

Risk based quality decision making. Review and provide options to meet business needs without compromising quality and compliance.

Share best practices, challenges and lessons learned within the site across the Quality organization in order to improve the performance of quality globally

KNOWLEDGE AND TECHNICAL COMPETENCES

- Demonstrated knowledge in cGxP regulations.

- Understanding of the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation

- Knowledge of MRP Systems and GMP impacting computer systems, like SAP, LIMS and software platforms typically used by the Company (TW NtM, TGO Pulse ect)

- Knowledge of Quality Systems, product types and manufacturing operations

- Ability to collaborate with internal team to manage a successful inspection and provide timely and thorough responses to the regulatory authority

- Ability to author response to inspection observations

- Ability to share information with internal colleagues regarding status of inspection and responses

- Ability to stay current with and apply in daily activities a strong working knowledge of cGXPs/ regulatory guidances to ensure full compliance

- Ability to understand and execute against Company Quality Management System

- Ability to promote continuous process improvement/ efficiency

- Ability to proactively analyze and assess processes and implement improvements resulting in compliant, effective and efficient operations for quality and the site.

QUALIFICATIONS

- Master Degree in Chemistry, Biology, Microbiology, Pharmacy or similar


EXPERIENCE

- 5 years working experience, min 3 years in GMP environment, continuous professional development

- Experience in managerial tasks in quality or manufacturing organization

- Experience with pharmaceutical processes, techniques, and cGXP

- Fluent in English

We offer a great professional opportunity, the compensation package will be commisurate with the experience gained and able to involve the most qualified candidates.

Luogo di lavoro:

Nerviano

Disponibilità:

Tipologia:

Full Time

Data pubblicazione:

05/06/2018

Codice annuncio:

500214187

Visualizzazioni annuncio:

655

Nome filiale:

LIFE SCIENCES

Numero di candidati ricercati:

1
NOTE LEGALI:
Manpower è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.manpower.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.

Compliance & Quality System Manager

Nerviano
Full Time
05/06/2018
500214187
655
LIFE SCIENCES
1

Azienda

Importante Multinazionale farmaceutica

Descrizione

We are currently looking for a Compliance & Quality System Manager for an important Pharmaceutical Company based in Lombardy near Milan.

Mission of the role:

Lead the sitès Quality Systems and Compliance team in establishing and maintaining quality at the department in accordance with Site SOP's, regulatory guidelines and cGXP compliance requirements.

Maintain high standards of quality at the department through managing and continuously improving the effectiveness of the department quality processes and systems.

Consistently measure, monitor and report site quality key performance indicators

Identify, develop, and retain qualified people to implement the quality processes. Run an efficient and effective Quality Systems organization through managing the department site budget and resources.

Build a team that has the technical expertise, personal skills and interpersonal skills needed to influence site Operations and is conversant in application of regulations

Foster and develop on site Quality Culture

Risk based quality decision making. Review and provide options to meet business needs without compromising quality and compliance.

Share best practices, challenges and lessons learned within the site across the Quality organization in order to improve the performance of quality globally

KNOWLEDGE AND TECHNICAL COMPETENCES

- Demonstrated knowledge in cGxP regulations.

- Understanding of the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation

- Knowledge of MRP Systems and GMP impacting computer systems, like SAP, LIMS and software platforms typically used by the Company (TW NtM, TGO Pulse ect)

- Knowledge of Quality Systems, product types and manufacturing operations

- Ability to collaborate with internal team to manage a successful inspection and provide timely and thorough responses to the regulatory authority

- Ability to author response to inspection observations

- Ability to share information with internal colleagues regarding status of inspection and responses

- Ability to stay current with and apply in daily activities a strong working knowledge of cGXPs/ regulatory guidances to ensure full compliance

- Ability to understand and execute against Company Quality Management System

- Ability to promote continuous process improvement/ efficiency

- Ability to proactively analyze and assess processes and implement improvements resulting in compliant, effective and efficient operations for quality and the site.

QUALIFICATIONS

- Master Degree in Chemistry, Biology, Microbiology, Pharmacy or similar


EXPERIENCE

- 5 years working experience, min 3 years in GMP environment, continuous professional development

- Experience in managerial tasks in quality or manufacturing organization

- Experience with pharmaceutical processes, techniques, and cGXP

- Fluent in English

We offer a great professional opportunity, the compensation package will be commisurate with the experience gained and able to involve the most qualified candidates.
NOTE LEGALI:
Manpower è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.manpower.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.