Browse by job sector

Deviation Specialist (Manufacturing)

  1. Cork
Dublin
  1. Contract
Competitive
  1. Life Sciences
11-08-2021
26870KF

This vacancy has now expired

Manufacturing Deviation Specialist - Ireland - Contract

This is an exciting chance to join a fast-growing project that has ambitious growth plans. It will give the ideal candidates a chance to have a genuine impact on a state-of-the-art aseptic pharmaceutical site. 

Description:
The manufacturing specialist will be primarily responsible for resolving deviations on an aseptic site.

Specific responsibilities include but are not limited to:
  • Working closely with Quality, Engineering, Process Development, Validation, Manufacturing, Inspection and Packaging to resolve deviations in a timely manner
  • Leading investigation teams in order to determine root cause, product impact potential, and Corrective and Preventative Actions (CAPA)
  • Writing Technical Deviation Reports, managing review and approval with key stakeholders.
  • Assuring appropriate escalation to various levels of management when timeline requirements for deviation processing are exceeded
  • Assisting as needed in audit by external agencies in answering questions related to deviations
  • Performing other duties as required by Manufacturing Management.

Requirements:  
  • Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
  • Detailed technical understanding of aseptic operations
  • Experience participating in and leading cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Strong technical writing and presentation skills
  • Ability to be flexible and manage change
  • Ability to communicate and collaborate with technical and management staff

Preferred Qualifications:
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions
  • Project Management experience
  • Experience interacting with representatives of regulatory agencies
If this role is of interest, please apply now.

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
Save as a job alert
List #1

Similar Jobs

Product Quality Manager

Salary

Competitive

Location

Brussels

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Brussels

Description

Product Quality Manager - Belgium - 12-Month Contract  We have an exciting opportunity for an Product Quality Manager based in Belgium to work with our esteemed client whose portfolio is

Reference

33993

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
Read more
Read more
Site Review Architect

Salary

Competitive

Location

Copenhagen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Denmark

Description

Site Review Architect - Pharma - 12-Month Contract - Copenhagen  Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Site Review Architect to join them on their new

Reference

33965

Expiry Date

01/01/0001

Megan Luxford

Author

Megan Luxford
Megan Luxford

Author

Megan Luxford
Read more
Read more
Procurement Administrator

Salary

Competitive

Location

Berlin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Central Germany

Description

Procurement Administrator - Pharma - Berlin  We're representing a top-tier global pharmaceutical company situated in Berlin. With significant capital investment and numerous ongoing projects,

Reference

32769

Expiry Date

01/01/0001

Jenny Latham

Author

Jenny Latham
Jenny Latham

Author

Jenny Latham
Read more
Read more

Insights

Life Sciences manufacturing in the UK: A Golden Opportunity with Adrian Wallis

Life Sciences manufacturing in the UK: A Golden Opportunity with Adrian Wallis
Read more

04/24/2024

Top Life Science Skills for 2024

Top Life Science Skills for 2024
Read more

01/25/2024

Living and Working in Milan

Living and Working in Milan
Read more

11/07/2023

VIEW ALL

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.

Send your CV
Upload your CV