Job Description

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

The QA Senior Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility in one of these areas: Quality Systems, QA Validation and Technical Compliance, Quality Compliance (Audit / External), Quality Operations (LBT) or Quality Operations (LBSS).

Key Responsibilities

• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
• In depth awareness of entire process; identifying operational factors which influence the process
  
• A competent Reviewer and Approver of SOPs, protocols, reports or records
• Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken
• Demonstrate ability to lead a small project and manage the deliverables effectively
• Develop good working relationships with internal & external customers
• Plan for future activities and coordinate with other departments to complete this
• Develop skills to be Qualified Trainer in area of expertise
• Any other tasks as and when assigned by supervisor.
• Uphold data integrity principle in accordance to Lonza policies. Proactively evaluate, identify and improve data integrity process.
  
  Additional accountabilities by area (if any):
  Quality Systems
• Able to participate actively or lead in deviation investigations, change controls and CAPA plans
• Able to lead and drive discussion on Quality System related issue
• QA Validation and Technical Compliance
• Provides QA oversight to QC/DS lab services, Engineering and Validation areas
• Able to be Change Agent, Reviewer or Approver of SOPs, protocols, reports or records.
• Provide QA oversight and approve deviation investigation, discrepancy reports and CAPA records. Participate actively, utilizing Root Cause Analysis tools to enable effective and timely closure of records. Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA.
• Provides Quality Change Request oversight for Lab services, Engineering, Validation changes.
• Detect non-compliance with cGMP and GDocP requirements and provide guidance on GDocP corrections
• Able to troubleshoot and propose solution. Able to weigh up all information and considerations in order to choose the optimum path to be taken.
• Liaise with cross functions, communicating information and updates in timely manner
• Develops good working relationships with internal & external customers.
• Participate in cross-functional walk down and provide feedback
• Lead and coordinate projects and manage the deliverables effectively.
• Qualified Trainer in area of expertise
• Develop skills to front auditors as SME/ supporting QA oversight
  
  Quality Compliance (Audit / External)
• Develop skills as an internal GxP auditor, as required
• Provide support in backroom / front room in regulatory inspections and customer audits as required
• Participate in walk down and provide usable feedback as required
• Able to lead in audit / inspection response as required.
• Able to lead, review and approve deviation investigations, change controls and CAPA plan as required
• Perform material release and qualification, joint inspection to identify material defect and review / approve vendor's investigation report as required.
• Leads and coordinate projects and manage the deliverables effectively.
• Qualified Trainer in area of expertise
  
  Quality Operations (LBT / LBSS)
• Review executed batch records and logbooks and ensure that deviations are raised.
• Compile lot genealogy.
• Compile lot disposition packages and drive lot disposition activities to ensure timely release of product.
• Provide oversight to product status, including preparation of documents for shipping activities.
• Provide oversight to quality tag out system
• Participate actively and approve deviation investigations, utilizing Root Cause Analysis tools to enable effective and timely closure of deviation investigations.
• Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA.
• Escalate process events on the floor based on knowledge of defined SOPs & policies
• Support and coordinate changeover activities.
• Provides Quality oversight for Operations document changes (e.g. MBRs, SOPs, Forms, Logbook, etc.).
• Provides Quality Change Request oversight for process and Operation change.
• Detect non-compliance with cGMP and GDocP requirements and provide guidance on GDocP corrections
• Participate in walk down/ QA On Shopfloor and provide feedback
• Supports / Participates in Regulatory and Customer Audits
• Leads and coordinate projects and manage the deliverables effectively
• Develops good working relationships with internal and external customers
• Able to troubleshoot. Able to weigh up all information and considerations in order to choose the optimum path to be taken

Required Qualifications

• Bachelor's Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Engineering, or related discipline.
• Minimum 3–5 years of relevant experience in Quality Assurance within a cGMP / pharmaceutical / biologics / medical device manufacturing environment.
• Strong knowledge of cGMP, GDP/GDocP, Data Integrity principles, deviation management, CAPA, change control, and quality systems.
• Experience in reviewing and approving SOPs, protocols, reports, batch records, logbooks, and validation documents.
• Hands-on experience supporting QA oversight for validation, engineering, laboratory services, manufacturing operations, or technical compliance activities.
• Familiarity with deviation investigations, Root Cause Analysis (RCA), audit support, regulatory inspections, and customer audits.
• Ability to identify compliance gaps, troubleshoot issues, assess risks, and recommend practical solutions.
• Good understanding of manufacturing processes, quality systems, and operational workflows within regulated environments.
• Experience coordinating cross-functional activities and managing small to medium-scale projects effectively.
• Strong communication and stakeholder management skills with the ability to work collaboratively across departments.
• Experience in batch record review, lot disposition, material release, or QA shopfloor oversight will be advantageous.
• Internal auditor certification and/or experience supporting regulatory inspections is preferred.
• Proficient in Microsoft Office applications and quality management systems such as TrackWise, Veeva, SAP, or equivalent systems.
• Able to work independently in a fast-paced manufacturing environment with strong attention to detail and compliance mindset.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.