Az álláshirdetés lejárt.
Aktuális állást talál az aktív állásajánlatok között: új keresés indítása itt
www.cvonline.hu

Quality Manager (Biotechnology)

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2015.08.07.
Jelentkezési határidő: 2015.08.20.
Hirdetés azonosító: 935170
lejárt

 

 
 
Quality Manager (Biotechnology)
Hays Life Sciences has been retained by a global leading manufacturer of diagnostics who wish to acquire a talented Quality Manager for their new reagents production plant in Hungary.

The purpose of the role is to support the plant start-up by developing and managing all aspects of site quality standards and Quality System.

Responsibilities:
• Manage the Quality Assurance and Regulatory Compliance staff and activities to support the transfer, manufacture and release of products in accordance with established specifications.
• Quality activities include, but are not limited to: inspection, validation, material disposition, product release, data collection/trend analysis, auditing, Quality/Compliance training.
• Manage nonconforming material, including complaint, processing, investigation and documentation. Provides quality metrics reports.
• Acts as Management Representative and main contact for all quality related matters.
• Works in conjunction with other functional leaders to assure the initial validation of the plant and its processes and the ongoing maintenance of the validation strategy.
• Works in conjunction with other functional leaders to ensure CAPA activities (investigations/corrective and preventive actions) are carried out in a timely and effective manner.
• Responsible for writing and implementation of quality procedures, strategies and policies. Reviews and approves all plant procedures and policies. Assures full implementation of cross site Change review Board.
• Is responsible for implementing and maintaining an ISO certified quality system in all departments in the facility.
• Builds an influential and effective relationship with other Plant Management Team members in order to drive overall Plant performance by leading a strong culture of Quality and Continuous Improvement.
• Recruits, manages, coaches and develops a team that achieves the business and Quality Assurance / Regulatory Compliance department and associates goals.
• Leads regulatory compliance activities (example: IACUC; REACh reporting etc.)
• Ensures all staff is trained in good quality and laboratory practices and documentation of other procedural based training.
• Identifies quality improvement opportunities within Operations and partners with peers in the Innovation center to develop and implement new processes and technologies.
• Participates in creating the department budget and pro-actively manages it to targets.
• Contributes to world-wide functional strategy and priorities and ensures effective deployment within the Plant.

Requirements:

• University degree in Life Sciences or Engineering discipline
• Minimum of 10 years of relevant Quality experience in Medical Device / Reagent / Pharmaceutical manufacturing industry
• Minimum of 5 years of experience in Quality leadership position including budgetary management
• Knowledge of applicable regulations (ISO 9001)
• Excellent communication and interpersonal skills are essential
• Ability to work under pressure and to tight deadlines
• Ability to work well with a team, be a good problem solver and an excellent leader
• Proven track record in dealing with regulatory authorities
• Fluent in both spoken and written English and Hungarian
• Working knowledge of: MS Office, Visio, Project planning and experience with SAP is preferred
• LEAN and/ or Six Sigma experience preferred
• Quality System start-up and project management experience preferred
• Extensive travel required in the first 6 months
Munkavégzés helye: Budapest
 
{{if LINK JELENTKEZÉS/APPLY }}

Egyéb hasonló állások Önnek
Szoftvertesztelő Mérnök

HAYS Hungary Kft.

Szoftvertesztelő pozícióba keresünk munkatársat...
Budapest


HW Projekt Menedzser

HAYS Hungary Kft.

HW Projekt Menedzser Hardverfejlesztés    Hardv...
Budapest


Production planner

Randstad Hungary Kft.

The world's leading power plant companies looki...
Budapest