Qualified Person - 12 Month Contract
- Employer
- Thornshaw Recruitment
- Location
- Dublin (County), Leinster (IE)
- Salary
- Negotiable
- Start date
- 21 Jun 2022
- Closing date
- 5 Jul 2022
View more
- Discipline
- Quality, Qualified Person
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
On behalf of our client, we are currently recruiting for a Qualified Person (QP) for Dublin for a 12 month contract role. The client is open to candidates being employed on headcount or contractors.
Responsible for the day to day QP certification of Products manufactured by or imported by company in line with Directive 2001/83/C as amended by Directive 2004/27/EC and described in Annex 16 of the EU Guide to GMP
QP Responsibility
- Act as Qualified Person on behalf of the company – responsible for the review of batch manufacturing records, process deviations, LIRs and disposition of the same in line with Directive 2001/83/C as amended by Directive 2004/27/EC and described in Annex 16 of the EU Guide to GMP. Provide QA support for EU importation of pharmaceutical products, and batch release for the EU Market. To be readily available to staff of company for discussion and advice and also be present during regulatory inspections, if required
Audit and assessment
- Preparation and execution of Risk Assessments Investigation and review of OOS validation results. Reporting of all investigations in line with procedures. 100% Participation in Regulatory and Customer Audits. Ensure a state of constant readiness for unannounced regulatory inspections. Produce reports on the audits and ensure that appropriate CAPAs are implemented where necessary.
Quality Management
- Review of PQRs Review and assessment of Change Controls Review/Approval of Packaging Specifications Preparation and update of Technical Agreements Review and update of SOPs, Specifications and SAMs where applicable Preparation and Review of the GMP Training modules Conduct GMP training as requested Performance of Internal and External Audits (including agenda preparation, report writing and CAPA close out) Investigation of Customer Complaints
Requirements
Essential
- Bachelor’s degree in chemistry, biology, pharmacy or a related discipline. Significant experience (5+years) within the quality assurance / quality control / compliance functions of the pharmaceutical industry. Eligible to act as Qualified Person releasing product into the Irish and European Markets Thorough understanding of quality systems and cGMPs Experience interfacing with regulatory bodies or working on regulatory submissions Experience with and fundamental understanding of EMA regulations and associated guidance documents Experience leading GMP audits, including drug product manufacturing and analytical testing.
Desirable
- MSc / Postgraduate Diploma in Pharmaceutical Manufacturing Technology or other related QP qualification Experience working with contract manufacturing organisations Finished product manufacturing, particularly sterile product manufacture Analytical method development or executing analytical methods Process validation and/or IT compliance Experience in defending processes, procedures and investigation during Regulatory inspections
For full details contact Linda at +353 1 2784703 or email your CV to ldunne@thornshaw.com. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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