Job Type: Perm
Job ID: JO-1908-19258
Consultant: Karen McHugh
Do you have 8+ years of biopharmaceutical QC experience or related quality control?
Have you team lead or management experience?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
QC Manager - Sample Management - Biopharma - Dun Laoghaire - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Supervision/Management of QC Sample Management team
Ensure the Sample Management area is operated in a safe manner
LIMS lot authorisation of commercial and Global IDP release testing.
Responsble for the ADL Stability programme
Responsible for management of Reference standards at the site
Out of hours responder for sample management equipment (fridges /freezers / incubators)
Sample shipments and temperature monitoring activities.
QC Representative for Sample Management at Amgen network meetings and sample management forum
Developing and coaching the QC Sample Management team.
Ensure timely completion of deviations through the Non-Conformance procedures.
Keeps abreast of current Corporate and industry requirements and compliance tends as they pertain to Sample Management and Stability.
Participate in regulatory agency inspections as required.
Manage and contribute to the achievements of department productivity and quality goals.
Conduct performance appraisal reviews for staff and identify training requirements for further development of colleagues.
Supervision/Management of QC Sample Management team and to maximise efficiencies and adequately support QC laboratories and other departments.
LIMS lot authorisation of commercial and Global IDP release testing on site. Liaise with site Planning, Manufacturing and Inspection regarding ADL manufacturing schedule and required QC testing.
Responsible for Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme requirements.
Responsible for management of Reference standards and reserves for the site including Reference Standards and assay controls, training and verification samples
Provide an effective and efficient QC service to operations by supervising, developing and coaching the QC Sample Management team.
Manage sample management activities across the site
With a high degree of technical flexibility, work across diverse areas within QC
Plan and perform routine tasks with efficiency and accuracy. Troubleshoot, solve problems and communicate with stakeholders.
Participate in audits and continuous improvement projects that may be departmental or organizational in scope.
Own and approve protocols, SOPs and documentation such as Equipment qualification. Initiate and/or implement changes in controlled documents and equipment. Maintain GMP equipment, including responding and management of GMP alarms.
Introduce new techniques/ Processes to the area, where appropriate. Seek out opportunity to improve Sample Management processes.
Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
May provide technical guidance. Provide coaching and support to the Sample Management team.
Contribute to regulatory filings as required.
May represent the department/organization on various teams. May train others.
Act as point of contact across Amgen network for Sample Management forum, Stability network, ABR for Global IDP release, QC testing for product launches in US, Europe etc.
Broad technical knowledge within Sample Management area and expanding knowledge of related disciplinary areasRecognizes and understands the cross-dependencies of the technologies and understands the impacts on the organizationEnhances own knowledge through understanding business trends and objectives
Knowledge of industry and business principlesUnderstands the core business process and purpose of the functional area in Amgen's commercialization process
Developing own project management techniques
Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information
Creates new procedures and processes to drive desired results
Handles diverse scope of issues that require evaluation of a variety of factors including current business trends
Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role.
Experience leading cross-functional teams is desirable
Work is guided by operational and project objectivesManages multiple assignments and processesIndependently determines approach to project
May be responsible for specific programs and/or projects
Independently develops solutions that are thorough, practical, and consistent with functional objectives
Contributes to work group/team by ensuring quality of tasks/services provided by self and others with a strong focus on RFT and Lean
Provides training and guidance to others
Extends capabilities by working closely with senior staff/experts within and outside the internal organization
Lead with initiatives to identify and drive improvements
Communication skills (verbal and written) at all levelsStrong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)Presentation skillsEscalate issues professionally and in a timely basis and know when to escalate
Decision Making skills – will be require to make decisions independently
Teamwork, Coaching and motivating others
Negotiation and Influence skills, Planning and organisation skills
Demonstrated ability to interact with regulatory agencies
Experience working with interdepartment and cross functional teams and influencing decisions
Project Management and organizational skills, including ability to follow assignments through to completion.
Bachelor’s degree in a Science related field is required.
6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with of 2 – 3 years of specific sample management/ stability programme management experience is desirable.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Strong working knowledge of LIMS and CIMS is preferred. Previous SAP experience while not required, would be an advantage.
€65 - 75K basic
Health plan for self & dependents
excellent pension plan
Annual performance related bonus
28 days annual leave
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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