The QA Specialist will support the quality oversight of the QA biologics development and external function. This includes all quality aspects at contract manufacturing operations for clinical and commercial manufacturing to ensure that the operational business follows cGMP, the Quality agreement, regulatory requirements and Quality Management system.
Responsible for ensuring new biologic drug development programmes are following EU/FDA and associated guidance’s
Responsible for ensuring consistency to management of the CMO and for ensuring the CMO is in compliance with the regulatory requirements and company standards.
ESSENTIALS AREAS OF RESPONSIBILITY:
- Serve as quality assurance support and SME for development and Drug Substance, Drug Product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing storage and shipping activities are compliant.
- Responsible for reviewing contractor documents i.e. batch records, deviations and change controls to ensure they comply with requirements.
- Responsible for batch disposition of drug product and Drug substances (clinical and commercial). Accountable for the on-time disposition of clinical/commercial products in line with the agreed schedule
- Act as the quality contact for CMO’s maintaining oversight at those CMO’s for quality-related topics
- Partner with colleagues to develop and negotiate quality agreements.
- Lead quality risk management activities both internal development programme and at the contract manufacturers organisation and manage mitigation plans with the CMO.
- Further develop the quality system to support the biologics development and Contract Manufacturing organization.
- Support all PPQ process and product-related activities for drug substance and drug product e.g. process charactersation, cleaning validation, process validation (including e.g. stability studies, hold time studies, review and approval of protocols).
- Preparation and development and maintenance of key performance indicators for the development and external quality biologics program to align with the company’s quality objectives. Analysis of quality statistics (Pareto Analysis) to drive improvements.
- Provide quality direction and input at the change review board and assume QA oversight of change controls ensuring scope of the record is clear and implementation activities are robust and timely.
- Ensure compliance of quality systems other applicable regulations/standards and internal procedures. Support implementing improvements at the CMO in deviation and changer control systems.
- Provide the requisite quality support to the regulatory/CMC group in support of licensee applications
- In conjunction with the supplier quality group ensure all quality agreements are aligned with the requirement expectation from the CMO and CTO organizations.
- Keep up to date with FDA/EU regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance for clinical commercialization.
- Build strong effective working relations with CMO’s from a quality and compliance prospective.
- Proactively support regulatory inspections at the CMO sites that may impact compliance status or require regulatory notifications.
- Provide quality leadership for change management and significant deviations at CMO sites
- Provide Quality leadership for customer complaints as applicable.
Education & Experience Requirements:
BS in scientific discipline or equivalent.
10-15 years’ experience in the pharmaceutical industry; preferably in biologics and/or aseptic/sterile processing
Experience in development/CMO operations preferred
Ability to interact effectively with health authorities
Strong communication skills and an ability to influence key stakeholders.
Demonstrated strong negotiation skills.
Demonstrated ability to prioritise work to act and work independently
Has a strong broad GMP and technical know how to handle emerging issues
Excellent verbal and written skills
Excellent interpersonal skills
The position will require up to 30% percent international travel
Personal Attributes Needed:
Team Player committed to quality; motivated self-starter; detail and results oriented; Well organised, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
Can get things done on the basis of influence.
Comfortable working in a fast-paced environment with multiple issues open simultaneously.
Customer service mindset
Identifies opportunities to improve and contributes to problem solving.
For further information on this QA 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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