Key Responsibilities
- Own discrepancies / non-conformance.
- Perform investigation and Root Cause Analysis (RCA) for the assigned discrepancies / non-conformance.
- Generate investigation report and work with other stakeholders and approver to get the write up approved.
- Write and edit relevant technical content.
- Partner with SMEs to capture specialized knowledge and translate it into clear instructions.
- Provide input on change requests, CAPAs, and related tasks, ensuring timely closure.
- Participate in planning and briefing meetings to align documentation with operational priorities.
Qualifications
- Bachelor's degree in Engineering (Chemical/Biochemical) or Science (Biochemistry, Chemistry, Microbiology) preferred.
- Experience in a cGMPregulated environment knowledge of biopharmaceutical manufacturing and sterile processing processes is an advantage.
- Strong technical writing and communication skills.
- Ability to translate complex technical concepts into clear, userfriendly instructions.
- Strong collaboration skills with crossfunctional teams and auditors.
- Track record of delivering projects under tight timelines.
Overview
We are seeking a Technical Writer / Investigator to join our team. In this role, you will be responsible for ensuring process issues are investigated and documented timeky and correctly.
What We Offer
- Career development: we will work with you and the client to give you a wider exposure to prepare for career consulting career.
- Teamwork: we deliver a service and not a manpower provider. You get a team to support you at your work and have fun together.
- Learning opportunities: we offer continuous learning through structured planning and development.
