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Job Details

Qulaity Assurance Officer

Company: Thornshaw Recruitment
Reference: TD9989
Closing Date: 14 Jan 19
Type: Permanent
Salary (£): On Application

Job Summary:

My client, a world class pharma company now have a vacancy for a Qulaity Assurance Officer.


My client, a world class pharma company now have a vacancy for a Qulaity Assurance Officer.

Reporting to the Quality Assurance Manager you will have responsibility for the development, implementation and maintenance of the company quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.
You will have responsibility to develop compliance across the site and ensure project plans and milestones are delivered according to agreed timelines.

Key responsibilities:

1.    Compliance:
?    To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
?    Represent Quality Assurance on various projects, change controls, deviations, investigations, CAPA and document approval.
?    Ensure high quality output – Vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
?    Initiate action to correct quality problem and notify others of quality issues as appropriate.  If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
2.    Continuous Improvement: 
?    To identify and make recommendations for improvements as part of a team within or outside the department to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
3.    Documentation:
?    To ensure review of all QC and production batch documentation when required and correctly to achieve a high level of customer service and cGMP.
?    To ensure preparation of Submission Documentation in support of licence applications
4.    Leadership:
?    Mentoring - support company with problem solving and skill development to aid learning and early problem resolution.
5.    Vendor Management: 
?    Ensure that Vendor Management program is adhered to.
6.    Technical Agreements:
?    Ensure that customer/ Contract services Technical Agreements are initiated and maintained.
7.    Customer requests:
?    Ensure that all customer requests are dealt with within a reasonable timeframe.
8.    Commercial Manufacture:
?    Review batch documentation in a comprehensive and timely manner. 
?    Notify management of any anomalies which could impact the quality, safety of efficacy of a batch. 
9.    Self-Inspection Program:
?    Ensure Self Inspections are completed as per the defined schedule.
10.    Inspections:
?    Participate in outside Inspections (Customer audits / Regulatory inspections)
11.    Vendor Auditing: 
?    Lead vendor audits of GxP services as required
12.     Safety:
?    Ensure requirements of Safety Statement are observed and promote a positive safety culture by leading by example
To perform additional team tasks as agreed to support effective running of the Business.

Qualifications & Experience:
•    Qualified to a minimum of degree level, preferably a Science degree incorporating Quality Assurance  
•    4-5 years’ experience working in a Quality Assurance role in a manufacturing environment an advantage.
•    Lead Auditor qualification an advantage

Working knowledge of Electronic systems such as Track Wise, Doc-compliance, SAP etc. an advantage.

For full details contact Tina at 01 2784671 or email your CV directly to

Apply for this job: Qulaity Assurance Officer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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