Title:  Senior Quality Assurance Engineer

Job Summary

The Quality Engineer deliver end‑to‑end Quality activities associated with technology transfer (TT) projects, ensuring compliance with regulatory requirements, internal quality standards, and customer expectations. This role operates with a high level of independence and collaborates closely with cross‑functional partners locally and globally to maintain product quality and support successful project execution.

Essential Duties and Responsibilities

• Provide Quality oversight for technology transfer projects, including prepare, review and approval of quality documents, protocols, risk assessments, validation activities, and change controls when required.
• Identify quality risks, assess impact, and ensure timely implementation of mitigation actions across different functions.
• Partner effectively with cross‑functional stakeholders such as Operations, Engineering, Supply Chain, and Global QA to ensure alignment on quality requirements and project deliverables.
• Ensure that TT activities comply with global regulatory standards (e.g., ISO, GMP) and internal Quality Management System (QMS) procedures.
• Conduct and support investigations, deviations, CAPAs, and non‑conformance documentation related to TT products and processes.
• Communicate and enforce quality expectations clearly and professionally to internal teams and external partners.
• Be Point of Contact on site to provide response and follow through customers’ queries on quality matters, including data requests, documentation, and quality agreements when required.
• Initiate or lead continuous improvement initiatives to enhance quality processes, reduce risks, and strengthen compliance culture.
• As the quality representative for TT related activities, participate and contribute to audits and inspections (internal, external, and customer) as and when needed.
• Monitor and facilitate all TT projects to meet and balance compliance requirements, operational efficiency, project timelines and customers’ expectations.
• Provide inspection plan for item creation and change, as well as set up ROS (Reference Operating Set) in SAP for item creation and change.
• Perform CCM (SAP Change Control Management) review from quality perspective when required.
• Conduct review of customer product specification quality documents and close any gaps needed including creating West product specifications for customers, if required.
• Participate in Quality shopfloor audits.
• Any other duties as assigned by the Manager.

Education

• Bachelor's degree or equivalent in Science or Engineering or relevant discipline

Work Experience

• Minimum 5 years of experience in Quality, Manufacturing or Engineering roles in a regulated manufacturing industry (preferably Elastomer or Pharmaceutical or Medical Devices or equivalent).
• Demonstrated ability to work independently and make sound decisions in complex situations.
• Strong understanding of GMP, QMS and validation principles.
• Proven experience collaborating with cross-functional and global teams.
• Excellent written and verbal communication skills wot the ability to convey complex information clearly.
• Strong analytical and problem-solving skills with proactive, quality-focused mindset.
• High level of business acumen and ability to balance quality, compliance and operational needs.
• Experience supporting technology transfer, validation or new product introduction is preferred.

Preferred Knowledge, Skills and Abilities

• Quality and compliance mindset
• Independent decision-making
• Collaboration and stakeholder management
• Effective communication
• Technical and analytical capability
• Project management awareness
• Business acumen
• Good understanding of Annex 1 requirement is an advantage
• Familiar with ISO 15378 and ISO 9001 is an advantage
• Attention to detail