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QC Supervisor at Orion Group
dublin county, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 20 year(s)
Sr Mgr Product Quality Integrator at Johnson & Johnson
dublin county, Dublin County, Ireland - Full Time
Skills Needed
N/A
Sr. Manager Product Management at GemPool Recruitment
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 6 year(s)
Senior Engineer - Civils at Sisk
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
(Senior) Business Analyst (m/w/d) at Cognitivo AG
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 6 year(s)
Financial Analyst at Recruit Ireland
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Lead Software Engineer at Bjak
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Data Engineer at Mentor Talent Acquisition
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Senior Solutions Architect at Fintech Ireland
Dublin County, Dublin County, Ireland - Full Time
Skills Needed
N/A
Quality Engineer at Apple
Dublin, South Dublin, Ireland - Full Time
Skills Needed
N/A
Business Development Manager at Ehrhardt AG
dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Test Automation Engineer at Version 1
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Test Analyst at Grant Thornton
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Compliance Analyst at LinkedIn
Belfast, Belfast-Northern Ireland, Ireland - Full Time
Skills Needed
N/A
Customer Experience Advisor - Full time at Yuno Energy
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
Project Coordinator / Planner at Harper Resourcing
dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Operations Coordinator at Morgan McKinley
dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Customer Service Analyst at Ohshima Ireland
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
Lead Software Engineer at Mastercard Ireland
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
DevOps Lead at CBASE INC
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
QC Supervisor at Orion Group
dublin county, Dublin County, Ireland -
Full Time

Start Date

Immediate

Expiry Date

03 Jan, 27

Salary

75000.0

Posted On

05 Oct, 26

Experience

20 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

About the job


Job Description

Reporting to the QA Director, the QA Operations Manager will ensure that sterile products (New Product Introduction (NPI) and Commercial) are manufactured, filled and released at the site meet the regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements that the product is been released too.

  • Main duties and responsibilities:Ensure that all NPI and Commercial Products manufactured are in accordance with the relevant GMPs.
  • Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial manufacturing processes within the site.
  • Management of site QPs and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
  • Ensuring that sterile and aseptic products manufactured at the site meet requirements of end users, Regulatory Authorities and of the company.
  • Verify that batches are manufactured and comply with the provisions of the marketing authorisation.
  • Ensure manufacture has been carried out in accordance with all applicable Good Manufacturing Practice, e.g., EU GMP Annex 1 and FDA regulations.
  • Ensure the principal manufacturing and testing processes have been appropriately validated; account has been taken of the actual production conditions and manufacturing records.
  • Confirm that any exceptions or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
  • Maintain knowledge and experience is up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
  • Ensure effective transfer of NPIs to site and its progress into clinical / commercial manufacturing
  • Work with QA Director, Quality Control and Quality Systems group to ensure site meets its customer, quality service, regulatory and financial goals.


Qualifications

  • Degree level qualification in a science discipline with previous experience in the healthcare/pharmaceutical industry.
  • MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
  • Industrial experience gained in a FDA and EMA approved pharmaceutical environment.
  • Previous supervisory and managerial experience in a manufacturing related area in a Biotechnology, Pharmaceutical or Medical Device organisation
  • Experience in manufacturing processes of drug product/substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations preferable.
  • Proven track record in audit management and regulatory interaction management.

How To Apply:

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Responsibilities

About the job


Job Description

Reporting to the QA Director, the QA Operations Manager will ensure that sterile products (New Product Introduction (NPI) and Commercial) are manufactured, filled and released at the site meet the regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements that the product is been released too.

  • Main duties and responsibilities:Ensure that all NPI and Commercial Products manufactured are in accordance with the relevant GMPs.
  • Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial manufacturing processes within the site.
  • Management of site QPs and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
  • Ensuring that sterile and aseptic products manufactured at the site meet requirements of end users, Regulatory Authorities and of the company.
  • Verify that batches are manufactured and comply with the provisions of the marketing authorisation.
  • Ensure manufacture has been carried out in accordance with all applicable Good Manufacturing Practice, e.g., EU GMP Annex 1 and FDA regulations.
  • Ensure the principal manufacturing and testing processes have been appropriately validated; account has been taken of the actual production conditions and manufacturing records.
  • Confirm that any exceptions or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
  • Maintain knowledge and experience is up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
  • Ensure effective transfer of NPIs to site and its progress into clinical / commercial manufacturing
  • Work with QA Director, Quality Control and Quality Systems group to ensure site meets its customer, quality service, regulatory and financial goals.


Qualifications

  • Degree level qualification in a science discipline with previous experience in the healthcare/pharmaceutical industry.
  • MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
  • Industrial experience gained in a FDA and EMA approved pharmaceutical environment.
  • Previous supervisory and managerial experience in a manufacturing related area in a Biotechnology, Pharmaceutical or Medical Device organisation
  • Experience in manufacturing processes of drug product/substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations preferable.
  • Proven track record in audit management and regulatory interaction management.
QC Supervisor at Orion Group
dublin county, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 20 year(s)
Sr Mgr Product Quality Integrator at Johnson & Johnson
dublin county, Dublin County, Ireland - Full Time
Skills Needed
N/A
Sr. Manager Product Management at GemPool Recruitment
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 6 year(s)
Senior Engineer - Civils at Sisk
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
(Senior) Business Analyst (m/w/d) at Cognitivo AG
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 6 year(s)
Financial Analyst at Recruit Ireland
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Lead Software Engineer at Bjak
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Data Engineer at Mentor Talent Acquisition
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Senior Solutions Architect at Fintech Ireland
Dublin County, Dublin County, Ireland - Full Time
Skills Needed
N/A
Quality Engineer at Apple
Dublin, South Dublin, Ireland - Full Time
Skills Needed
N/A
Business Development Manager at Ehrhardt AG
dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Test Automation Engineer at Version 1
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Test Analyst at Grant Thornton
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Compliance Analyst at LinkedIn
Belfast, Belfast-Northern Ireland, Ireland - Full Time
Skills Needed
N/A
Customer Experience Advisor - Full time at Yuno Energy
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
Project Coordinator / Planner at Harper Resourcing
dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 2 year(s)
Operations Coordinator at Morgan McKinley
dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Customer Service Analyst at Ohshima Ireland
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
Experience Required
Minimum 3 year(s)
Lead Software Engineer at Mastercard Ireland
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A
DevOps Lead at CBASE INC
Dublin, Dublin County, Ireland - Full Time
Skills Needed
N/A