Job Details: Quality Assurance Manager


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Quality Assurance Manager
Kelly Services are recruiting for the excitingt role of QA Manager
with a Waterford based pharmaceutical company. The QA Manager Sterile
Fill Finish is responsible for all aspects of the assigned QA Team
and. Provides QA oversight to ensure that all drug product
manufacturing activities are compliant with company policies,
procedures and in accordance with cGMPs.  

The successful candidate will have minimum 8 years? experience in
the biopharmaceutical industry.

RESPONSIBILITIES: -

* Support the Head of Quality with the quality function oversight
* Maintain the EirGen Pharma, Pharmaceutical Quality System to
include: Personnel, Premises & Equipment, Production, QC, Outsourced
activities, Complaints, Investigations, Self-Inspections
* Ensure all work carried out is compliant with company standards,
cGxP, SOPs, regulations and guidelines, safety and environmental
guidelines
* Continuously promote a positive safety culture. Implement Safety
requirements as per site documentation including SOPs, Safety
Statement
* Collaborate cross functionally with all departments and represent
Quality on the Sterile Supply Value Stream - Investigations management
and approval a. Deviations & Complaints b. Out-of-Specifications,
Out-of-Calibrations, Out-of-Trends
* Elevate Quality issues to the Head of Quality and Senior
Management where required, working collaboratively with the Sterile
Fill Finish Manager to provide direction and support in critical
interventions
* Manage Self Inspection Program
* Manage and host site Inspections (Customer audits / Regulatory
inspections etc.)
* Batch documentation review ensuring compliance to standards and
SOP?s - Batch package preparation for QP release
* Manage Vendor Qualification
* PI and excipient disposition
* Primary & Secondary component disposition
* Provide oversight of any Contract Manufacturing activities related
to Sterile Fill Finish
* Manage metrics, performance and review with the Site Leadership
Team
* Quality management representative on EirGen?s Area Management
Team , ensuring effective running of the business
* Involved in the recruitment, leadership and career development of
Quality Assurance members
* Creation of Quality department goals aligned with site strategy
and objectives
* Performance evaluations for direct reports - Quality department
budgeting
* To perform additional tasks as agreed to support effective running
of the business.

 

MINIMUM REQUIREMENTS

 

* Primary degree in a scientific discipline
* Minimum 8 years? experience in the biopharmaceutical industry, 5
of which should be within a Quality function
* Minimum 4 years leadership experience, including team coaching and
development
* Experience of Quality Assurance of aseptic medicinal products and
in particular biopharmaceuticals.
* Experience in using lean methodologies and / or operating within
Value Streams
* Candidate is eligible to act as a Qualified Person as described in
EU Directives, would be an advantage
* Extensive knowledge of electronic QMS systems ? EDMS, ERP,
TrackWise etc.
* Experience preparing and hosting Customer & Regulatory Inspections
* Lead auditor experience

Kelly Services are recruiting for the excitingt role of QA Manager
with a Waterford based pharmaceutical company. The QA Manager Sterile
Fill Finish is responsible for all aspects of the assigned QA Team
and. Provides QA oversight to ensure that all drug product
manufacturing activities are compliant with company policies,
procedures and in accordance with cGMPs.  

The successful candidate will have minimum 8 years? experience in
the biopharmaceutical industry.

RESPONSIBILITIES: -

* Support the Head of Quality with the quality function oversight
* Maintain the EirGen Pharma, Pharmaceutical Quality System to
include: Personnel, Premises & Equipment, Production, QC, Outsourced
activities, Complaints, Investigations, Self-Inspections
* Ensure all work carried out is compliant with company standards,
cGxP, SOPs, regulations and guidelines, safety and environmental
guidelines
* Continuously promote a positive safety culture. Implement Safety
requirements as per site documentation including SOPs, Safety
Statement
* Collaborate cross functionally with all departments and represent
Quality on the Sterile Supply Value Stream - Investigations management
and approval a. Deviations & Complaints b. Out-of-Specifications,
Out-of-Calibrations, Out-of-Trends
* Elevate Quality issues to the Head of Quality and Senior
Management where required, working collaboratively with the Sterile
Fill Finish Manager to provide direction and support in critical
interventions
* Manage Self Inspection Program
* Manage and host site Inspections (Customer audits / Regulatory
inspections etc.)
* Batch documentation review ensuring compliance to standards and
SOP?s - Batch package preparation for QP release
* Manage Vendor Qualification
* PI and excipient disposition
* Primary & Secondary component disposition
* Provide oversight of any Contract Manufacturing activities related
to Sterile Fill Finish
* Manage metrics, performance and review with the Site Leadership
Team
* Quality management representative on EirGen?s Area Management
Team , ensuring effective running of the business
* Involved in the recruitment, leadership and career development of
Quality Assurance members
* Creation of Quality department goals aligned with site strategy
and objectives
* Performance evaluations for direct reports - Quality department
budgeting
* To perform additional tasks as agreed to support effective running
of the business.

 

MINIMUM REQUIREMENTS

 

* Primary degree in a scientific discipline
* Minimum 8 years? experience in the biopharmaceutical industry, 5
of which should be within a Quality function
* Minimum 4 years leadership experience, including team coaching and
development
* Experience of Quality Assurance of aseptic medicinal products and
in particular biopharmaceuticals.
* Experience in using lean methodologies and / or operating within
Value Streams
* Candidate is eligible to act as a Qualified Person as described in
EU Directives, would be an advantage
* Extensive knowledge of electronic QMS systems ? EDMS, ERP,
TrackWise etc.
* Experience preparing and hosting Customer & Regulatory Inspections
* Lead auditor experience



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Type: Permanent
Payment:
Category: Others

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