Quality Associate

Desired Skills: Quality Record Management,GMP,Manufacturing,Ariba,Veeva,TrackWise,Deviations

*** This is a remote role the vast majority of the time and candidates can be based anywhere in the ROI. The team typically meet on site 1-2 times per month. However, workers must be willing to have more of an onsite presence in Dublin during the early weeks for induction and training ***

The Sr Associate Contract Development & Manufacturing provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality.

Working within the diverse Commercialisation & Performance Execution (CPE) team, this role works in partnership with different departments & stakeholders to ensure a smooth manufacturing process and compliance with quality standards. The role helps provide information insights and data analysis; identify problems and troubleshoot to evaluate options and solutions; drive precision through the execution of transactional/tactical tasks to ensure Contract & Development Manufacturing (ACDM) work cell (hub) success.

The role also requires applying process, operational, and scientific expertise, as well as basic compliance knowledge and analytical and troubleshooting abilities, to support quality records originating from manufacturing sites throughout our External Supply network. Additionally, the role provides a strategic dimension to the External Supply manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients – Every Patient, Every Time.

Responsibilities

Manufacturing Operations: The successful candidate is expected to own and execute various quality record types, including Deviations (Major/Minor), CAPA, SICAR, Change Control and perform metrics oversight responsibilities. Liaise with Third Party CDMOs to maintain and monitor systems to ensure all record received are appropriately investigated and concluded per our quality standards and procedures. Support/Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools. Optimise deviation management, corrective and preventive actions effectiveness to prevent reoccurring events.

Site Performance Monitoring: Report Third Party CDMO site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT),  oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team

Teamwork: Facilitation of cross-functional teams (internal and external to External Supply). Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions. Participate in the assessment or implementation of continuous improvement projects or initiatives. Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.

What we expect of you

The successful candidate for this role will bring the following education, skills and experience. 

Preferred Requirements:

• Master’s Degree (L9) in Business Administration, Engineering or Science-related field
• Bachelor’s Degree (L8) in Business Administration, Engineering or Science-related field, with 2+ years of experience in GMP protein, API, DS, DP or packaging manufacturing environment
• Ordinary Bachelor’s Degree or lower (L7 or lower) in Business Administration, Engineering or Science-related field, with 5+ years of experience in GMP protein, API, DS, DP or packaging manufacturing environment
• Experience in roles requiring knowledge of cGMP principles, FDA and other regulatory agency guidelines, and validation principles
• Understanding of applicable manufacturing/testing processes (i.e. protein, API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Preferred Competencies:

• Strong technical background with understanding of pharmaceutical manufacturing, commercialisation, and cGMP knowledge / experience.
• Problem-solving, critical thinking and decision-making skills.
• Demonstrated negotiation skills, accountability to deliver results and meet deadlines while handling contending priorities.
• Technical writing and multi-level communication skills.
• Demonstrated ability to perform effectively in a collaborative/team environment.
• Demonstrated ability to take initiative, drive action, and work under minimum supervision.
• Proficiency in Microsoft Office especially Project, Excel, PowerPoint, Visio, and Smartsheet
• Demonstrated experience with QMS & Digital tools including Veeva Vault, TrackWise, AI software.
• Experience with supporting/managing Third Party CDMO sites

(Workers may be required to travel to CMO facilities 1-2 times per year (expenses will be covered))

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***