QC Raw Materials & Compendial Team Lead

QC Raw Materials and Compendial Team Lead 12mth FTC

As QC Raw Materials and Compendial Team Lead you will be responsible for be responsible for carrying out tasks and supporting projects related to the QC testing and release of raw materials ensuring that the highest standards of GMP, GLP and Regulatory are strictly adhered to.

Department Description

As QC Raw Materials and Compendial Team Lead you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the Associate Director for Quality Control (QC) Raw Materials and Compendial.  This role is being offered as a 12mth FTC.

Your Responsibilities

• In this role, you will be a Key member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.


• Achieve a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.


• Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.


• Perform routine and non-routine testing activities as required.


• Ensure that all testing is completed, reviewed, and approved within agreed turnaround times.


• Ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.


• Train other QC analysts and manufacturing personnel in laboratory methods and procedures when required.


• Write/update and review TMs (Test Methods), SOPs (Standard Operating Procedures) and WIs (Work Instructions) as required.


• Write and review invalid tests, non-conformances and deviations as required.


• Initiate and drive change controls to completion to implement process improvements.


• Actively participates in lean initiatives such as Kaizen, 5S and Gemba.


• Perform all duties in accordance with GMP requirements, SOPs and controlled documents


• Flexibility to take on additional tasks and responsibilities at the discretion of the Associate Director of QC Raw Materials and Compendial.


• Will act as a role model for the QC function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

The ideal candidate for this position, will have the following:

Education

• University degree in related science/quality discipline required.

Knowledge/Experience:

 Required:

• Experience working in a QC function in a ‘greenfield’ context of similar size and scale is ideal.


• Expertise in the release of GMP materials and participant in QC activities, such as method transfer, validation etc.


• Experience in Biopharma analysis is desirable.


• Experience with LIMS, Empower etc is desirable.


• Experience troubleshooting in testing issue resolution is desirable.


• Experience in method transfers is desirable.


• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory. Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals

Preferred:

• Experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.


• Previous experience managing and leading a small team would be advantageous.


• Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required.


• Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required.


• Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable.


• Previous experience working in a CMO is an advantage.

Personal skills:

• Strong leadership competencies with demonstrated management skills.


• Excellent interpersonal, verbal, and written communication skills.


• Able to think critically and demonstrate troubleshooting and problem-solving skills.


• Self-starter and self-motivated; organized with good attention to detail.


• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.


• Results oriented, with the ability to manage multiple priorities in a short period of time.


• Collaborative and inclusive approach to work and your colleagues.