QA Specialist Operation
13 hours ago
Job Description:
As a Specialist, QA (CGT) at Lonza, you will support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. You will play a key role in providing QA oversight for operations, compliance, and documentation, ensuring that products meet the highest quality standards and are released on time.
What you'll get
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Daily company bus from the MRT location near your home to and from the Tuas site.
- Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.
- Access to Lonza's full global benefits portfolio:
What you'll do
- Review executed batch records, logbooks, and documentation to ensure compliance with cGMP and GDocP.
- Compile lot genealogy and disposition packages to drive timely product release.
- Provide QA oversight for product status, shipping documents, and quality tag-out systems.
- Support and approve deviation investigations, CAPA implementation, and timely closure of quality events.
- Oversee and approve changes to operational documents (e.g., MBRs, SOPs, Forms, Logbooks).
- Participate in QA shopfloor activities, changeovers, walkdowns, and audits (regulatory/customer).
- Lead and coordinate site projects, investigations, and change controls as needed.
What we're looking for
- Degree or Diploma in Science or Engineering.
- Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals.
- Strong knowledge of cGMP, GDocP, and applicable regulatory requirements.
- Hands-on experience with batch record review, deviation management, and CAPA implementation.
- Proven ability to lead investigations, change controls, and cross-functional projects.
- Effective communication and stakeholder management skills
Applications will be considered only if applied to the provided JD link
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