Senior QA Specialist API

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Senior QA Specialist API to join our contingent workforce. You will be working in EQ Small Molecule API department of J&J in Geel. This will be a contract opportunity to start asap, for 1 year, with a high possibility of an extension (long term purpose)!

This is an off site - on site position with on site access to Geel and Beerse.

Project Scope:

• This position will be reporting to External Quality (EQ) Manager/Senior Manager. This position provides the support to EQ Manager/Senior managers regarding Quality Assurance, Compliance and Technical Support for external manufacturers. Provides QA support for technology transfer, PPQ, NPI introduction and improvement of existing manufacturing processes.

• Contributes to the overall development, implementation, and execution of quality systems in support of the commercial production of Janssen products at external manufacturers. Ensures proactive and continuous compliance with applicable Health Authority regulations and J&J standards, including effective risk management.

• Conducts batch record review, investigations, performs audits, collects data, analyzes trends, and prepares reports as required. To provide support to EQ manager/senior manager on data collection during Escalation of any major/critical issues as appropriate and provide supports to EQ manager/senior manager during the Management Reviews.

Your Responsibilities:

• Ensure the success of external manufacturer qualification and monitoring, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. Provides balanced management of quality and compliance risks with business needs.
• Ensure effectuate and permanently maintain inspection readiness at the external manufacturers, including on site representation during regulatory inspections and audits. And support EQ manager/senior manager to drive development of corrective actions plans, as needed.
• Continuous oversight and management of:
• Quality activities during manufacturing and quality control (including validations, issue management, trouble shooting, change management, supplier, and material management)
• Execution of monitoring and auditing activities (including creation of quality agreements)
• Assessing quality systems and recommending improvements to enhance quality
• Reporting of quality activities, and as needed escalation of issues to senior JSC management

Minimum requirements: 

• Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry / Technical / Process technology / Chemical Engineering Required. 
• Experience in API, drugs or biologics quality management or manufacturing are essential to success. Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development will be a plus. Experience in presenting issues to all levels of the organization will be a plus.
• Ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers is required. Including proven ability to support Regulatory inspections and Heath Authority exposure.
• Demonstrated experience with API manufacturing and Quality control is preferred. Including understanding of typical unit operations, process equipment and analytical techniques (HPLC, GC, IR, wet chemistry testing, …).
• Demonstrated experience with quality activities during API process development, upscaling, validation, and launch is preferred. Including understanding of filing requirements and regulatory support.
• Interpersonal skills are required to build long term relationships, influence up and down, negotiate acceptable outcomes, multiple disciplinary, cross-cultural environments in External Manufacturers and J&J. This will be a plus.
• Ability to travel a minimum of 5-10% is required. 
• Fluent in English.

If you meet our requirements and are interested in hearing more about our Senior QA Specialist API role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!