Quality Associate

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

SUMMARY OF ESSENTIAL FUNCTIONS

·       Demonstrate good organizational, teamwork and effective problem-solving skills.

·       Independent and flexible to manage dynamic tight schedules to support the operational activities.

·       Self-motivated and result oriented to ensure task activities execution and deliver the expected results.

·       Understand GMP guidelines and Quality system to ensure operational activities are executed to GMP requirements and SOPs expectations.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES

Materials Management

 ·       Manage and ensure products/materials are appropriately stored at the designated locations and lot status correctly assigned in the inventory system.

·       Support incoming products/materials inspection activities to ensure conformance to requirements, including preparation of inspection reports.

·       Authorize the release of incoming products/materials from the inventory system.

·       Execute new material qualifications (eg label component), including preparation of inspection reports.

 Operational Activities

 ·       Support 100% inspection activities for potential product issues where applicable.

·       Authorize approval of label print setup process in Catalent Prisym to facilitate label printing activities.

·       Participate in secondary packaging in-process inspection activities to ensure the process conform to the requirements.

Training Programs

 ·       Ensure timely completion of Compliance-Wire assigned SOP training prior to the related work activities execution.

 Documentation

 ·       Participate in SOPs development and updates to support Catalent EDMS system.

·       Manage the site documentation system to ensure effective retrieval and archival of documentation.

 Catalent System

 ·       Track the quality system performance indicators and establish the trend analysis.

·       Participate in quality improvement initiatives assigned by management team.

Other Activities

 ·       Participate in discussion and resolution of potential quality concerns arise in daily operational related activities.

·       Report potential inconsistent work practices and non-compliance process activities.

·       Participate in review and approval of equipment calibration reports for acceptance.

·       Support the non-routine tasks assigned by the management team.

POSITION REQUIREMENTS

Education and Experience:

·       Degree / Diploma preferably in Pharmaceutical or Science disciplines.

·       3+ years’ work experience in Medical / Pharmaceutical related organizations.

·       Good knowledge preferably with experience in Regulatory/International Standards (eg. ISO9001, HSA Guidelines, PIC/S Guidelines, etc) will be an added advantage.

 Knowledge/Skill Requirements:

·       Good understanding of GMP guidelines and adopt standardize SOP procedures.

·       Able to manage assignments effectively and efficiently under pressure.

·       Detailed oriented with effective interpersonal skills.

·       Demonstrate good analytical and critical thinking skills.

·       Positive thinking and possess a growth thinking mindset approach.

·       Possess some computer knowledge/software, eg MS Office, JDE, Trackwise, etc

·       Able to manage teamwork and take self-initiative with minimum supervision.

·       Comfortable in cold/frozen temperature routinely (with appropriate PPEs).

·       Comfortable in working at a height of max 4-5m when needed (with appropriate equipment).