Quality Assurance Specialist

QA Specialist

Location: Leiden

Duration: 12 months

Hours: 40 hpw. Hybrid (3 days on-site)

Provides QA support to the commercial/clinical production at the Leiden/Sassenheim AT manufacturing site. Acts as the primary point of contact for all AT quality related topics within the site (i.e., production facilities and quality control labs). Provides Quality oversight to the manufacture of Drug Substances/Starting Materials in AT. Provides independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. The experienced specialist QA works in close collaboration with other departments (Operations, QC, Warehouse, MAM, MSAT). Reports to Manager QA AT and works together with other specialists QA. Other internal contacts include colleagues, both at operational and managerial levels, and all departments within manufacturing site. External contacts: Quality and Non-Quality representatives within the IMSC companies.

roles and responsibilities

• Provides Quality oversight to the AT Production facility at the site  

• Supports setting the GMP standards and/or provides Quality guidance for:

  • all GMP processes, e.g., Change Control, Doc Control, GMP Training, inspection readiness

  • Facility, utility, and equipment design for e.g., the new Pollux Facility

  • Technology and/or Analytical Transfer

  • Qualifications and Validations

  • Aseptic Processing and Annex 1 adherence

• Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition. 

• Provide Quality support for the development of appropriate Corrective and Preventative actions and provides Quality approval

• Escalate serious quality, compliance and /or GMP incidents to Site or Global Management and support (Global) escalation of issues, which have potential impact on the delivery of products to patients

• Participate in Hazard / Risk assessments to ensure compliance or quality is not jeopardized

• Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, Qualifications etc.) for site colleagues to ensure compliance to cGMP and company training requirements.

• Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and the laboratory

• Provide review and approval of document changes and change controls

• Lead or act as member for local or global capacity/quality projects

• Optimize current and identify new ways of process and quality monitoring

• On a rotation basis is available 24/7 as QA representative for Quality issues

• Act as quality SME and participates in the preparations for (APR, Inspection readiness reports) and during inspections (FDA, EMA etc.) to accomplish a successful audits.

• Partner with site colleagues to ensure all site changes (e.g., to production processes, equipment, and systems) are conducted in a controlled and systematic manner and conform to cGMP and other regulatory requirements.

how to succeed

Minimum education required for the position

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.

Minimum experience required for the position:

• Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC)

• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.

Other Requirements

• Proven knowledge of the biotechnological/pharmaceutical industry

• Proficiency in English both in word and in writing

• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment.

• Functions independently in a complex environment to make daily judgment to balance business need, regulatory requirements, and cost efficiency for all Quality decisions. Is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.

• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation.

• Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues. 

• Ability to drive collaboration in a fast-paced environment 

• Has good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints.

• Empowered professional who can make well motivated pragmatic decisions on their own.

details

This is a 12 month contract. 

Hybrid working hours (3 days on-site)

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.