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QA Mentor

Eingestellt von Harvey Nash IT Recruitment Belgium

Gesuchte Skills: Support, Engineering

Projektbeschreibung

One of our clients, a multinational company in the pharmaceutical industry currently requires a GMP Mentor

FUNCTION DESCRIPTION

The mission of a GMP Coach/Mentor is to support the Manufacturing Performance Unit (Formulation, Filling) and support services (Maintenance, QC, Warehouse) to increase their Quality over sight, according to their needs their reality.
The ultimate goal being to build on our existing concepts ie Quality Mind-set; Right First Time;
Everyone is responsible for Quality being more proactive in developing and implementing CAPA (Corrective Action Preventive Action) to address deficiencies

KEY RESPONSIBILITIES

The following key responsibility areas are applicable for this mission:

1) Facilitate the enhancement of Quality Systems with a direct impacton KPI, achieving continuous compliance of all Quality Systems:

- Deviation and CAPA Management
- Audit & Inspection
- Training & Documentation

2) Change Management: Support the move to the recent MPU model where:

- Supervisors are more present on the shop floor
- Quality is integrated in the MPU

3) Capture and share best practices for knowledge transfer across Units

Some concrete examples are described below:

- Support a sustained implementation of a robust "Deviation, Investigation and CAPA" management program.
- Help QA shop floor to build up their expertise according to GxP (sampling, documentation practices, In Process Control, )
- Sustain FDA Compliance Mind Set and raise general staff awareness to Quality Compliance
- Help teams to improve aseptic behaviour in close collaboration with the Aseptic coaching & mentoring programme

However, the most important is to have a sustainable change management approach, focused on Quality mind-set and behaviours by applying two leadership approaches:
mentoring and coaching style as define below:

PREREQUISITES

A team of mentors/coaches is being put in place and will be selected based on 2 focus area:
* Outstanding experience in QA and/or production activities
* Strong capabilities to engage and develop teams and individuals

Education:
PhD or Master in Sciences linked to Biotechnology/Vaccines development (Engineering, Bio- engineering, chemistry, ) or equivalent by experience.

Experience:

Minimum 10 - 15 years of relevant professional experience in industrialenvironment related to vaccines production is mandatory.
The same number of years of experience in Quality Assurance (QA) in Pharmaceuticals or Biologicals Manufacturing Operations industry is mandatory
Inspection and Audits experience is strongly required
- FDA/NDA/China/Europe/.
- Site preparation for Inspections

Strong experience in Change Management is also a pre-requisite
Relevant experience in people development and team management
Multiple experiences in several work environments/industries/companycultures is a plus

Knowledge:

Good Manufacturing Practices (GMP) knowledge is a must have
Management of quality systems: Deviation, CAPA, Audit, self inspection,

Skills:

- Fluent in French (both written and spoken) is mandatory, as well asgood knowledge of English.

However, we will not systematically reject candidates that are notfluent in French, as long as they are fluent in English, and that their team/individual engagement skills are excellent.

- Hands-on approach (able to work on the shop floor with a coaching and mentoring style to impact individual experiences)
- Strong communication skills (able to communicate with different levels within Unit)
- Influencing skills
- Flexible mindset
- Knowledge sharing

Tags: QA, Quality Assurance, GMP, Training, CAPA, Filling, QC, Pharmaceutical, FDA, Quality, Assurance qualité, AQ

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Belgium

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