Join our client in this Senior QA position and play a key role in maintaining top-tier quality standards If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.
QA Senior Specialist
12 month contract - Hybrid
This position is responsible for Quality Assurance (QA), primarily with QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control record management and providing a reliable source of information and accurate interpretation of quality, cGMP compliance requirements and quality systems, together with maintaining good working relationships with QA departments at contract facilities.
Occasional travel may be required as part of this role
Please note that to be considered for this role you must have the right to work in this location
Responsibilities
For the assigned products and area of Global Quality Operations and International Quality Operations:
Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements. This includes:
Building and maintaining a good working relationship with the contractor
Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, Out of Specification (OOS) records, processes, methods, procedures, documentation, etc.
Recommending quality related improvements to the contractor
Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
Manage change control requests. This includes, as necessary:
Initiating and approval routing of change control requests
Performing QA evaluation and endorsement/approval
Review of associated contractor change control requests
Monitoring progress of related action items
Escalation of change controls as required
Process product complaints. This includes, as necessary:
Providing support for complaint investigations related to external vendors as required
Approving complaint investigations where required
Review, edit, negotiate improvements to, and approve contractor documentation, including:
Process validation protocols and reports
Transfer validation protocol and reports
Investigations, Deviations, OOS records
Lead review of Annual Product Quality Review reports, as necessary. Edit, and negotiate improvements to contractor supplied Annual Product Quality Review reports.
Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
Participate in self inspections as appropriate
Participate in external audits of contractor manufacturers and distributors as assigned
Ensure logs, databases and files related to the product quality activities are maintained
Performance of trend reviews and compilation of metrics
For non-product related duties:
Develop and/or maintain pharmaceutical quality systems, as assigned
Author and/or revise standard operating procedures and associated work instructions, as assigned
Review and provide recommendations on policies and standards, as assigned
Support GMP/GDP site inspections, as assigned
Maintain compliance with personal training requirements
Required Competencies
In depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets
Ability to assess the right balance between business targets and scientific and quality decisions
Strong analytical and problem solving skills
Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate
Good communication and organizational skills
Project management skills
Development, organization, and execution of the Pharmaceutical Quality System within the Global Quality Organization
Must have computer proficiency
Required Qualification(s) and Desired Experience:
BSc or equivalent in scientific discipline
Proven years of experience in Quality Assurance in a pharmaceutical company.
Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
Experience in interacting with external manufacturers and supporting quality at external manufacturing sites
For more information, please contact Frankie Cunningham.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.
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