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Job Details

Qualified Person (QP) / Cork / Global Biopharmaceutical Company

Company: i-Pharm Consulting
Location: Cork
Reference: ALQP60910
Closing Date: 23 Oct 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Qualified Person (QP) / Dublin / Global Biopharmaceutical Company Qualified Person is required for a Global Biopharmaceutical Company. This is an excellent opportunity to work with a worldwide company. You will be responsible for the certification of batches for release to market. ...

Requirements:

Qualified Person (QP) / Dublin / Global Biopharmaceutical Company

Qualified Person is required for a Global Biopharmaceutical Company. This is an excellent opportunity to work with a worldwide company. You will be responsible for the certification of batches for release to market. This is a contract role based in Cork

JOB TITLE
Qualified Person / QP

LOCATION
Ireland / Munster / Cork

PAY RATE
Generous Hourly Rate in Line with Experience

ROLE/DESCRIPTION

- Release of IMPs
- Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
- Documentation supporting "QP" release for the QP team
- Planning and scheduling of the QP resource to ensure maintenance of operating
Capacity
- Approve Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
- Provide guidance and advice to QA and Supply Chain groups with respect to
QP release of products
- Maintain knowledge of legislation and subsequent changes
- Provide QA GMP support and technical direction to QA teams
- Lead and participate in investigation of deviations and investigations
including root cause analysis. Communicate quality issues to
management.
- Coordinate investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Lead on internal GMP audits of manufacturing facilities and systems and work to
resolve audit observations as required

REQUIREMENTS

- Eligible to act as a Qualified Person under EC Directive 2001/83 EC
- Bachelor’s Degree (B.S.), in Pharmacy, Chemistry, or Biology.
- Relevant work experience in a cGMP pharmaceutical manufacturing or R&D
Environment
- Sterility background would be desirable
- Strong QMS background
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
- Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA)) is beneficial.
- Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. 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 Principal Consultant Aisling on +353 14854994, or email alane@i-pharmconsulting.com. If this role is not suitable, Aisling is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


KEYWORDS

Qualified Person / QP / Ireland / Munster / South / Manufacturing / BioPharmaceutical / Pharmaceutical / GMP / Cork

Apply for this job: Qualified Person (QP) / Cork / Global Biopharmaceutical Company

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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