QA Senior Specialist

No deviation Pte Ltd.; Singapore; Hybrid; SGD 110,000 - 160,000; Full time

Job summary

No deviation Pte Ltd. in Singapore seeks a QA Senior Specialist to advance day-to-day quality assurance activities across cGxP contract manufacturing.

You will review SOPs, participate in deviations, CAPA, audits, and change controls, ensuring data integrity and compliance with regulatory standards. Responsibilities span QA validation, technical compliance, and cross-functional collaboration with QC, Engineering, and Validation teams to release products on time while maintaining the highest

Qualifications

• Bachelor's Degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Engineering, or related discipline.

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 weigh up all information to choose the optimum path.
• Demonstrate ability to lead a small project and manage the deliverables effectively.

Skills

Quality Assurance

cGMP

Data Integrity

Deviation Management

CAPA

Auditing

Education

Bachelor's Degree in Life Sciences

Job description

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.

Position Overview

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 Validationand Technical Compliance, Quality Compliance (Audit / External), QualityOperations (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 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.