QA Executive

2 weeks ago

Nilai, Malaysia Royce Pharma Manufacturing Sdn. Bhd. Full time

Compliance 1. To control, issue and check all the BMRs issued to production. 2. To review and final approval of completed BMRs and CoA as per batch release procedure. 3. To oversee the overall Compliance system management 4. Responsible to coordinate and monitor Deviation Management and Non-Conformance. 5. To monitor, follow-up and update the closure of Corrective Action and Preventive Action (CAPA) Management for both internal and external inclusive Supplier CAPA, ISO audit & cGMP audit. 6. Responsible to assist/perform Supplier/Vendor Audit. 7. To assist Quality Assurance Head in planning and execution and implementation of Quality objectives and Management Review Meeting with relevant departmental progress updates. 8. Prepare new or revise or review existing Standard Operating Procedures and other documents which are related to the aspects covered compliance and quality system related. 9. To carry out any other job/tasks assigned by Quality Assurance Head as and when required. Validation 1. To coordinate and perform validation activities and ensure Process and Cleaning Validation are completed as per schedule. 2. To prepare protocols, reports and compile all the validation documentation associated with Process Validation (PV) and Cleaning Validation (CV). 3. To prepare new BMR to be used by Production Department based on Research and Development's BMR. 4. To revise and amend BMR when necessary and review changes made in BMR either by Production or Research and Development R&D). 5. To manage and update any related QA Validation and Qualification Standard Operating Procedures (SOP). 6. To be responsible to ensure the Validation Master Plan (VMP) is updated periodically. 7. To perform monthly Environmental Monitoring activity for the production area.
We will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live.
Bachelor's or Equivalent

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