Role Overview:
Responsible for providing oversight for Quality on-the-floor and operations support, the QA Associate will support manufacturing operations and In-Process Control testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations.
* Required to perform 12-hour shift (rotational night and day, or full night shift as required due to business needs). There is shift allowance for day and night shift.
Responsibilities:
- Support the maturation and continuous improvement of the Organisation’s quality systems, including on-the-floor quality oversight, non-conformances, change control and Corrective and Preventive Actions (CAPA).
- Ensure that the systems are managed in compliance with Current Good Manufacturing Practice (cGMP) expectations.
- Participate in on the floor triage and support root cause investigations for non-conformance.
- Review and approve non-conformance investigations, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders.
- Support in regulatory inspections, and interact directly with regulatory inspector.
- Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation.
- Escalate any significant event to Quality management in a timely manner.
Qualification & Requirements:
- Graduate Degree in Science and 1 year of directly related experience; OR, Undergraduate Degree in Science and 1 to 3 years of directly related experience; OR, Undergraduate Diploma in Science and 5 years of directly related experience.
- 1-3 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems.
- Direct experience with bulk manufacturing of biopharmaceuticals preferred.
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations).
- Ability to communicate and collaborate effectively with technical and senior management staff.
Work Hours
per business schedule :-
- Day Shift: 8am – 8pm (inclusive of 1-hour lunch break)
- Night Shift: 8pm – 8am (inclusive of 1-hour meal break)
- Swing Shift: Per Company's request, 12 hours shift (inclusive of 1-hour lunch break) – 2pm – 2am
