Job Description
The QC Stability Specialist will be responsible for developing and maintaining functions of Quality Control and ensures that all activities are fully in compliance with cGMP standards. The QC Stability Specialist will be responsible for performing key Quality tasks in respect of Company products. The QC Stability Specialist works in Quality Control within the Technical Operations department, which oversees analytical testing, stability programs, and contract manufacturing operations.
Reporting to the Associate Director Quality Control.
Responsibilities:
Management of stability programs for all products
Lead out-of-specification (OOS), out of trends (OOT) analytical deviations
Provide analytical/technical support to Technical Operations and CMOs
Ensure that operations within CMOs and contract testing laboratories are compliant with cGMPs
Manage analytical method transfers/validation programs in compliance with regulatory/ requirements
Operate CAPA/deviation, training and compliance systems
Develop and author SOPs, analytical validation protocols, and reports.
Implement and improve Quality Systems to realise the highest quality standards attainable for all activities conducted by the company.
Report on Quality Control Metrics
Lead trending programs for all products on release and stability
Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA's).
Management of reference standard programs for all products
Ensure of compendial method updates implemented as appropriate for products
Identify and implement Continuous Improvement programs as appropriate
Work closely with other members of Technical Operations/Development groups and CMOs to ensure delivery of key project objectives
Assist with troubleshooting quality control issues at CMOs when required.
Maintain appropriate Quality Technical Agreements with all GxP vendors
Supporting regulatory submissions as required
Education & Qualification
Bachelor's degree in chemistry, biology or a related discipline
At least 3-5 years' experience working in a laboratory/quality environment with excellent knowledge of cGMPs.
Experience in finished product pharmaceuticals/biologics/ APIs
Experience with analytical investigations, change control and documentation management
Strong Interpersonal skills and professional skills to interact at all levels including senior management, contractors, and colleagues
Excellent communication and time management skills
For further information on this QA Stability Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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Responsibilities:
Management of stability programs for all products
Lead out-of-specification (OOS), out of trends (OOT) analytical deviations
Provide analytical/technical support to Technical Operations and CMOs
Ensure that operations within CMOs and contract testing laboratories are compliant with cGMPs
Manage analytical method transfers/validation programs in compliance with regulatory/ requirements
Operate CAPA/deviation, training and compliance systems
Develop and author SOPs, analytical validation protocols, and reports.
Implement and improve Quality Systems to realise the highest quality standards attainable for all activities conducted by the company.
Report on Quality Control Metrics
Lead trending programs for all products on release and stability
Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA's).
Management of reference standard programs for all products
Ensure of compendial method updates implemented as appropriate for products
Identify and implement Continuous Improvement programs as appropriate
Work closely with other members of Technical Operations/Development groups and CMOs to ensure delivery of key project objectives
Assist with troubleshooting quality control issues at CMOs when required.
Maintain appropriate Quality Technical Agreements with all GxP vendors
Supporting regulatory submissions as required
Education & Qualification
Bachelor's degree in chemistry, biology or a related discipline
At least 3-5 years' experience working in a laboratory/quality environment with excellent knowledge of cGMPs.
Experience in finished product pharmaceuticals/biologics/ APIs
Experience with analytical investigations, change control and documentation management
Strong Interpersonal skills and professional skills to interact at all levels including senior management, contractors, and colleagues
Excellent communication and time management skills
For further information on this QA Stability Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
Follow us on Facebook, Linked-in, Twitter