Compliance Specialist – Technical Operations
- West
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland.
Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.
Role Summary:
- Completes investigations of technical deviations for department issues of noncompliance.
- Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
- Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
- Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies, and procedures.
- Completes investigations of technical deviations for department issues of noncompliance.
- Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
- Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
- Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies, and procedures.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
- Strong interpersonal, written, presentation, communication, and investigation skills with the ability to engage with a diverse range of individuals across all levels of the organisation.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
To view Quanta's privacy policy, please visit our website
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
Save as job alert
Similar Jobs
Salary
Competitive
Location
Ohio
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
North America
East Coast
Description
HSE Officer / LOTO Lead Coordinator - US, Ohio - 12 Months Contract This is a fantastic opportunity for a HSE Officer / LOTO Lead Coordinator to join our major, global pharmaceutical client on
Reference
36944
Expiry Date
01/01/0001
Author
André VázquezAuthor
André VázquezSalary
Competitive
Location
Ohio
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
North America
United States
Description
LOTO Coordinator - US, Ohio - 12 Months Contract This is a fantastic opportunity for a LOTO Coordinator to join our major, global pharmaceutical client on their latest new-build project based in
Reference
36945
Expiry Date
01/01/0001
Author
Annabel NangleAuthor
Annabel NangleSalary
Competitive
Location
Ohio
Salary
Competitive
Sector
Compliance / Quality Assurance
Job type
Contract
Location
North America
East Coast
Description
CQV Field Engineer - Utilities - US, Ohio - 12 Months Contract This is a fantastic opportunity for a CQV Field Engineer - Utilities to join our major, global pharmaceutical client on their latest
Reference
36943
Expiry Date
01/01/0001
Author
Annabel NangleAuthor
Annabel NangleInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Christopher
I manage this role.