Quality Specialist
Baxter International
Total years of experience :12 years, 4 Months
1. In charge of analysis of renal IV solutions for peritoneal dialysis (PD1, and PD4) and IV solutions (Ringer lactate, Normal Saline, Dextrose 5%). Their raw material, in process, and final product.
2. Handling product complaints.
3. Writing and executing the analytical method validation protocols and SOP.
4. CAPA, OOS, OOT, change controls, and deviation management.
5. Purified water (water for injection) analysis.
6. Inspect the QC lab on regular basis to ensure compliance with cGMP, and GLP.
7. Write and review QC SOPs.
8. Assist in the training of new hires.
JOB PURPOSE:
A) Qualification & Validation
- In charge of supervising Qualification and Validation of complete plant and corresponding equipment’s /materials
- Ensure that qualification and validation are maintained on plant equipment’s
B) Plant SOPs leader
- to lead, to establish and to maintain all plant SOPs
C) Quality inspection
- Ensure regular inspections and reports with default list and improvement proposals
JOB DIMENSIONS:
Critical tasks of the job will be :
1. Establish, supervise and control Qualification and Validation of the facility
- Establish Plant qualification and validation master plan,
- Ensure that all protocols are ready, in line with Master Plan and completed with all the company's standards & rules to be applied and checked,
- Monitor the execution of Qualification and Validation,
- Follow-up qualification and validation results, failure report, out of specification and check complete documentation approvals,
- Inspect on an regular basis to ensure that qualification and validation documents / data are still valid and accurate.
2. Establish complete SOPs system - Supervise and control SOPs correct implementation
- Establish SOPs Master Plan, including the complete list of all SOPs implemented or to be implemented in KAEC facility,
- Supervise Sops writings,
- Ensure plant workers SOPs training with training registration supported by training programme,
- Check the correct implementation of the SOPs,
- Maintain the SOPs system with upgrading the Master plan following audits, inspections, and new standards implementation
3 - Quality, validation (1) and Sops(2) job perimeter concerns all the plant including production, QC laboratory, warehouse, maintenance, utilities and waste.
3. Assist and support Quality team when requested.
1. Preparation of standard operating procedures; specifications for bulk / intermediate / finished products
2. Analysis of bulk / intermediate / finished products samples using chemical and instrumental methods.
3. Approval and release of bulk / intermediate / and finished products to QA department
4. Operation, use and calibration of analytical instruments.
5. cGMP / GLP compliance in QC laboratory
6. Documentation as per cGLP.
7. Compliance with USFDA, MHRA, TGA, EU requirements for testing in a quality control laboratory.
8. Maintain inventory and records for chemicals, spares, columns.
9. Assists in training of new QC staff/trainees.
1. Preparation of test procedures, specifications for bulk / intermediate / finished products
2. Analysis of bulk / intermediate / finished products samples using chemical and instrumental Methods.
3. Approval and release of bulk / intermediate / and finished products to QA department
4. Operation, use and calibration of analytical instruments.
5. cGMP / GLP compliance in QC laboratory
6. Documentation as per cGLP.
7. Compliance with USFDA, MHRA, TGA, EU requirements for testing in a quality control laboratory.
8. Maintain inventory and records for chemicals, spares, columns.
9. Assist in training of new QC staff.
1. Analysis of bulk / intermediate / finished products samples using chemical and instrumental Methods.
2. Operation, use and calibration of analytical instruments.
3. cGMP / GLP compliance in QC laboratory
4. Documentation as per cGLP.
5. Compliance with USFDA, MHRA, TGA, EU requirements for testing in a quality control laboratory.
6. Maintain inventory and records for chemicals, spares, columns.