Job Description

Requirements:

Degree in Chemistry, Chemical Engineering or Biology OR Degree in any Science discipline. 1-3 years working experience in pharmaceutical manufacturing industry. Excellent verbal & written communication skills, knowledge of quality standard, able to work in team and attention to details. Proficient with Microsoft Office Suite or related software.

Job Summary:

Responsible for all of the documents and processes in a company. To ensure that the architecture of a company is set up so that everything will be documented correctly. A few of the main duties of a document controller are updating crucial procedures, ensure all documents are accessible, communicating with auditors, and organizing documents. Assist Head of QA in QA matters related with compliance and continue improvement.

Key Accountabilities:

To report to Head of QA on any quality system matters related to compliance with PICs, GDP, GDPMD guidelines and pharmaceutical quality system. To assist Head of QA in conducting routine cGMP, GDP and GDPMD training as per PICs, GDP and GDPMD guidelines for existing staff and new hiring. Promote GMP, GDP and GDPMD awareness and enforce practices in order to ensure GMP, GDP and GDPMD compliance is met and in accordance to PICs, GDP and GDPMD requirement. Responsible for controlled document controls and coordinate document change request for controlled document change, review, approval, distribution, retrieval and retention as per Controlled Document and Record requirements. To ensure external documents used as a reference such as PICs, GDP, GDPMD guidelines and relevant Annexes is current and communicate changes with Head of QA. To maintain log and capture identification and traceability for Batch Record, Document Change request and other documents related to QA system. To initiate controlled document review program and ensure all controlled document/ record are updated accordingly. To coordinate artwork management and update Approved Artwork master list. To issue BMR and BPR for production use. To ensure contract agreement is updated and valid for external service providers. To involve and assist in risk management at respective quality scope and area. To assist in any external audit and provide post-inspection follow up information as requested. To support and perform other QA Executive duties when he/she is absent or out of office. Ensure adherence to company policies. To work as a team to achieve company objectives. To undertake any other duties as directed by the Immediate Supervisor and Management as and when required.
Job Types: Full-time, Permanent

Pay: RM2,400.00 - RM3,500.00 per month

Benefits:

Additional leave Dental insurance Flexible schedule Free parking Health insurance Maternity leave Meal allowance Opportunities for promotion Professional development Vision insurance Work from home
Work Location: In person