QA Specialist-Hybrid

PSC Biotech® Corporation; Carlow; Hybrid; EUR 42,000 - 59,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

PSC Biotech Corporation in Ireland seeks a quality professional with 3–5 years of pharma manufacturing experience to oversee supplier management and quality systems. The role involves review of documentation for new products, deviation handling, CAPA, change controls and regulatory compliance.

Hybrid work arrangement with 2–3 days on-site. 11-month contract. Bachelor’s degree in a related science preferred; strong writing and collaboration skills are required.

Qualifications

• 3–5 years of experience in a quality role within pharmaceutical manufacturing.
• Knowledge of Irish, European, and International Codes, Standards and Practices.
• Familiarity with cGMP and GDP is preferred.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Strong report, standards and policy writing skills.
• Experience or familiarity with Lean Six Sigma methodology is desired.
• Good collaboration skills and ability to work as part of a team to determine priorities.
• Demonstrated ability to work independently and take ownership of improvement initiatives.
• Proven ability to drive task completion and demonstrate accountability.

Responsibilities

• Supplier Management oversight.
• Quality Agreement management & APR Quality Agreement Chapter owner.
• Review documentation for new product and material introduction (Material Packs, QC Test Specifications, BOMs, Supplier Qualification).
• Develop and monitor supplier performance metrics and participate in reviews.
• Maintain the qualified Supplier Management system and ensure correct setup of suppliers and materials.
• Support deviation, CAPA initiation and follow-up.
• Support change controls & Supplier Complaints.
• Provide quality oversight for introduction of new products and materials; manage external parties.
• Author, review, and approve protocols and reports for technology transfer, method qualification and validation.
• Ensure site compliance with divisional policies and regulatory requirements; participate in cross-functional committees.
• Participate as a functional expert in cross-functional teams introducing products and materials.

Skills

Quality control

Regulatory knowledge

cGMP

GDP

Lean Six Sigma

Microsoft Office

Problem solving

Team collaboration

Independent contributor

Decision making

Accountability

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Role Functions:

• Supplier Management oversight
• Quality Agreement management & APR Quality Agreement Chapter owner
• Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification and Oversight.
• Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
• Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used .
• Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
• Support change controls & Supplier Complaints.
• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties including periodic re-evaluations.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials .

Requirements

Experience, Knowledge & Skills:

• A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
• Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
• Strong report, standards, and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.
• Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
• Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
• Proven ability to drive the completion of tasks.
• Strong decision-making capability with a sense of accountability and responsibility.
• Demonstrated problem-solving skills

Qualifications & Education:

• A Bachelor's degree or higher in a related Science discipline is preferred.

Additional Notes:

• Hybrid, usually 2/3 days per week on site
• Day role
• 11 Month Contract
• Application Deadline: 12th Oct