QA Staff Qualification & Validation (Outsource)

QA Staff Qualification & Validation

Position Summary:

The QA Staff Validation & Qualification Specialist is responsible for ensuring that all equipment, utilities, systems, and processes comply with regulatory and quality standards through rigorous validation and qualification protocols. This role involves drafting, reviewing, and executing qualification documentation, compiling and analyzing data, and troubleshooting non-conformances or deviations. Working closely with cross-functional teams and external vendors, the specialist drives compliance, develops standardized operating procedures (SOPs), and provides technical support across site projects to maintain operational excellence.

Qualification:

• Pharmacy graduated or Apothecary

• Fresh graduates are welcome, but having experience in Qualification and Validation process in Pharmaceutical Manufacturing is an advantage

• Understand the fundamental principles of CPOB 2024 (GMP) especially Chapter 12 on Qualification and Validation

• Understand the fundamentals of Data Integrity and Good Documentation Practice (GDP)

• Familiar with Microsoft Office/WPS, Excel, and statistical data

• Willing to be hired under third party

• Placement at Cikarang Selatan

Key Responsibilities:

• Prepare the validation/qualification protocols, reports and any supporting documents

• Execute and support validation/qualification activities in site,

• Support any projects related to the validation/qualification activities in collaboration with other relevant departments

• Compile and review validation/qualification data

• Raise any issue regarding non-conformance or deviation related to the validation/qualification activities

• Ensure compliance and provide technical support during validation/qualification

• Develop SOPs related to the validation/qualification activities

• Possible to be the key personnel (PIC) in relation with third parties/vendors