Senior Supervisor - Quality Engineering

About the role

The role is based in the Manufacturing plant and is required to apply validation, qualification, and calibration practices. You are required to look into validation, qualification, and calibration processes, recommend solutions, improvements, and increase the productivity of the team.

Key responsibilities

• Create validation and qualification master schedule each year

• Monitor implementation of validation and qualification master schedule monthly

• Create protocol and report of process validation product

• Create protocol and report of production and laboratory equipment qualification

• Create protocol and report of utility qualification

• Create escalation form or deviation report if validation/qualification results do not meet acceptance criteria

• Create change control if any changes happen during validation/qualification activity

• Verify conformity of activity process validation and qualification against standard

• Give standard execution guidance of process validation and qualification to user and external vendor

• Give recommendations of process validation and qualification results to user for implementation

About you

• Diploma in Science or Technical with minimum two years experience in validation, qualification, or calibration

• Technical bachelor's degree, Pharmacy bachelor's degree, or Pharmacist qualification

• Familiar with QC laboratory instruments, production equipment, and utility production

• Good knowledge about validation, qualification, and calibration

• Good knowledge about production processes (mixing, filling, and packing)

• Good knowledge about critical operational points of equipment and utilities

• Good knowledge about ISO 13485, ISO 9001: 2015, ISO 14001: 2015, ISO 45001: 2018, ISO 22716: 2007, and Halal Assurance System (HAS) 23000

• Good communication skills and fluent in English (written and spoken)

• Strong analytical skills and good time management

• Able to work individually and in teams

• Greenbelt will advantage