Quality Assurance Supervisor (Pharma)

PRIMARY FUNCTION AND BASIC PURPOSE

Ensures implementation of the Quality and Regulatory requirements in the plant including customer standards to meet or exceed the Quality expectations. Ensures that the organization meet the requirements given by the clients through direct coordination and oversee implementation of created Master Packaging Order.

RESPONSIBILITY AND ACCOUNTABILITY

A. JOB EXPECTATION
1. Correct creation/revision of Master Packaging Order in accordance with the packaging instruction given by the client prior issuance.

2. Direct monitoring and implementation of GMP, Quality, Regulatory and Customer requirements in the organization.

3. Direct coordination to all customers for on time assessment, review, and initiation of investigation to any concerns raised by the customers. Provides input such as root cause, correction and corrective action that may help in addressing nonconformities raised during audits, inspections, and verification processes.

4. Timely evaluation and ensure completeness of batch records for the final release of all finished goods.

B. RESPONSIBILITIES
1. Ensures that all documents pertinent to the creation and implementation of Master Packaging Order from the client is available prior approval and review of the QA Manager or designate. Responsible for the product release.

2. Ensure proper coordination with the cGMP Inspector with regards to the routinary conduct of in-line inspections in the production. This includes review and checking of the generated IPQA, temperature monitoring and results of different tests conducted by the cGMP inspector.

3. Ensures proper coordination with the QC Inspector with regards to the conduct of in-line inspections in the warehouse. This includes review of the bulk inspection forms, temperature monitoring and results of different tests conducted by the QC Inspector.

4. Handles Standard Operating Procedures creation, revision and review. Recommends the need for creation of documented information for processes under and related to the Quality Assurance Department.

5. Handles, manages and monitors deviation and CAPA reporting either internal or external.

6. Initiates, manages and monitors investigation using different methods such as Gap Analysis, Risk and Impact assessment to ensure on-time closing of complaint reports.

7. On-time updating of KPI Reports from the clients and ensure proper documentation.

8. Ensures that all activities conducted by the QA/RA Analysts are checked and reviewed at all times, inclusive of all documentations for the creation of the MPO and additional requirements needed by the customer such as GMP Certificate, photo documentations, receiving reports, discrepancy reports, inventory reports, and other documents.

9. Directly coordinates with the PPIC Team to ensure proper approval and review of the created Master Packaging Order; and all other additional requirements from the clients.

10. Regularly conduct line inspections, to ensure implementation of established SOPs and generated packaging orders.

11. Coordinates directly with clients and QA Manager with regards to creation of KPI Reports and Quality reviews, including compliance to the customer inputs. Prepares necessary documentation needed during any external and internal audits.

12. Provides disposition for any internal issues raised during production, and coordinates to all relevant internal and external parties the result of disposition considering the quality of products being produced.

13. Create, revise, and cascade procedures and work instructions related to Quality Assurance.

14. Coordinates with the Purchasing Staff with regards to all quality related requirements set by both internal and external interested parties including customers and regulatory agencies.

15. Coordinates with the Production team for the result of any quality-related concerns raised including proper documentations.

16. Responsible for reporting any significant changes or deviations found in the line to QA Manager.

17. Responsible for conducting any special tasks that the QA Manager or designate may
assign.

PERFORMANCE STANDARDS

1. Timely release of Master Packaging Order.
2. Timely address of any external and internal interested parties’ needs and requirements
3. Timely release of complete and correct Quality Assurance reports
4. Conformance to Good Manufacturing Practices and compliance to Safety, and other regulatory requirements.

IV. KEY ORGANIZATIONAL RELATIONSHIP

1. Reports directly to QA Manager; RA Manager (if necessary)
2. Will take post for all activities of QA Manager, except approval of batch records release.
3. Coordinates with:

• Production Department
• Warehouse Department
• PPIC Department
• IT Department
• Accounting and Purchasing Department
• Quality Assurance Department
• Regulatory Affairs Department

4. In the absence of the Senior QA Analyst, the QA Analyst/s will take post.

V. QUALIFICATION REQUIREMENTS

1. College level or graduate in any 4 years course related to pharmaceutical industry
2. Preferably experienced in pharmaceutical industry and with relevant knowledge to Quality Management System, PICS and cGMP
3. Diligent and keen observant
4. Good in oral and written communication
5. Computer Literate

NOTE: Preferably 4 years, with background on GMP, PIC/S, FDA Requirements, ISO 9001:2015 and other Pharmaceutical Standards