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QUALITY SPECAILIST
Company:RFT GROUP |
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Job Reference Number |
14348057 |
Client ID: |
RI/RFT97568LK |
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Posted On: |
Jul 29 2010 |
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Location: |
CONNACHT, GALWAY |
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Job Type: |
Permanent |
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Salary: |
€NEG |
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The QA Specialist will have the experience of working within a pharmaceutical manufacturing facility with particular emphasis on process validation and technical support. Experience in Co-ordination & implementation of Process Analytical Technology (PAT) & Statistical Process Control (SPC).
Responsibilities
Reporting to the Quality Engineering Supervisor, the Quality Specialist will be responsible for the following activities:
Preparation & co-ordination of Process Validation protocols and reports for drug formulation processes and finished product combination devices in conjunction with Engineering and R&D.
Preparation and co-ordination of Equipment & Software Validation protocols & validation activities in conjunction with R&D & Engineering
Provide quality engineering support to manufacturing, helping to ensure delivery of the highest production yields
Understand & ensure compliance with the company's & external regulatory quality systems requirements
Use and establish analysis techniques & other quality control tools to aid in decision making
Identify opportunities for process & quality system improvements and work with task teams in implementation
Investigating root cause of quality issues and following through on corrective actions to prevent reoccurrence.
Participation as quality representative on technology transfer projects for combination devices.
Preparation and co-ordination of Cleaning Process Validation and Stability protocols and reports in conjunction with Engineering and R&D.
Qualifications
Quality Specialist will have a Bachelor of Science Degree in Science/ Engineering particularly in Chemistry/ Pharmaceuticals/ Biopharmaceuticals.
2 / 3 years experience in a Pharmaceutical Manufacturing Facility, Combination Product Facility or related environment with direct experience in a QA environment (GMP regulated). Knowledge of regulatory requirements and guidelines, namely CFR Parts 210, 211 and 820, ICH and ISO13485 is necessary.
Call Laurentina Kennedy on 01 2302400 for further information or email your CV to laurentina@rftgroup.ie Skype: rftgroup-laurentina-kennedy
No CV or details will be submitted to any potential client without prior knowledge, discussion and consent from "every" candidate.
The RFT Group: BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website: www.rftgroup.ie/ www.meddevicejobs.ie
