Quality and Compliance Manager/PV Manager - Freelance- Belgium
- Employer
- i-Pharm Consulting
- Location
- Belgium
- Salary
- Negotiable
- Start date
- 8 Apr 2019
- Closing date
- 22 Apr 2019
View more
- Discipline
- Clinical Research, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
QA Validation engineer
Purpose of the Mission
Provide QA support and oversight to validation activities according to validation procedures
Primary Tasks & Responsibilities
Provide a compliance expertise in validation
- Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
- Review/Approve the validation documentation regarding the GMP requirements and the Vaccines procedures
- Ensure that production practice are aligned with validation conclusion
- Attend all project meetings as QA validation representative
- Ensure timely escalation to Management of critical issues during validation
- Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
- Work in autonomy with supervision/coaching
- To define the validation strategies through the change control process
- To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
- To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
- To support the production, QA and technical service teams in the implementation of the validation activities.
Experience, Knowledge & Soft Skill Requirements
Required Experience & Knowledge
ü Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
ü Knowledge of GMP / CFR / Eudralex …
ü Knowledge of different regulations and standards related to validation activities
Soft skills:
ü Good interpersonal relationship skills
ü Good oral and written communication skills in French & English
ü Problem solving and achievement oriented
ü To be a good team player in order to succeed in each validation project and routine activities
ü To be able to use a risk-based approach for problem solving and prioritization of tasks
Education, Methodology & Certification Requirements
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
ICT Skills
Knowledge of SAP, documentum, … is an asset.
About i-Pharm Consulting
i-Pharm Consulting is a global specialist recruitment company servicing the pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
www.i-pharmconsulting.com
To apply
If you would like to discuss this vacancy further, please call Youssef Maachou on +31 20 808 14 84, or email ymaachou@i-pharmconsulting.com. If this role is not suitable, Youssef is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
Keywords
Pharma / pharmaceutical / biotech / manufacturing / clinical / distribution / medical devices
Benelux / Netherlands / Utrecht / Amsterdam / Eindhoven / the Hague / Maastricht / Rotterdam / Dutch / computerised systems / computerized systems / CSV / computer system validation / computer systems validation / Recruiter / recruitment / contract / permanent / career opportunities / QA / quality assurance / quality control / officer / manager / validation / audit / project manager / project management / research / cell therapy / manufacturing / production
Company
i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.
We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.
Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world.
With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.
For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them.
As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.
We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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