Quality Business Partner

He/She will be registered as warehouse’ Responsible Pharmacist and Qualified Person of Importation Health Supplement and Cosmetic and support Country Quality Head to develop, ensure and maintain the implementation of a quality management system in accordance with the standards set by Global Opella and applicable regulations.

Job Description

1.    Ensuring supporting document as Registered Responsible Pharmacist (Registered certificate, Responsible Pharmacist License) are valid and incompliance with the regulation.

2.    Focus on managing warehouse operational activities under his/her authority and maintaining the accuracy and quality of documentation, including
2.1. Product Receiving
2.1.1.    Ensure the vendor are listed as approved vendor
2.1.2.    Ensure the correctness and validity of delivery documents
2.1.3.    Sign purchase order, good receipt, and any other relevant documents during product receiving
2.1.4.    Proceed release process in the inventory system, except the products which the MA license under PT Opella Healthcare Indonesia

2.2.    Order Processing
2.2.1.    Ensure the customer are listed as approved customer
2.2.2.    Ensure the correctness and validity of purchase order issued by customer 
2.2.3.    Ensure the purchase order are proper and reasonable
2.2.4.    Perform Good Issuance in the inventory system
2.2.5.    Issue and signed Delivery Note to customer 

2.3.    Free sample issuance
2.3.1.    Review document for requesting sample and ensuring sample is prepared according to related procedure 
2.3.2.    Perform Good Issuance in the inventory system
2.3.3.    Issue and signed Delivery Note to receiver

2.4.    Handling of Imported Cosmetic and Health Supplement 
2.4.1.    Ensure sampling of imported cosmetic and health supplement is proceed as per relevant standard procedure, including sample issuance in the system 
2.4.2.    Perform temperature monitoring review of imported product (if any) 
2.4.3.    Perform checking of imported cosmetic and health supplement as per relevant standard procedure

2.5.    Handling of retention sample 
Ensure retention sample is handled as per relevant standard procedure including storage, documentation and temperature monitoring (if required). 

2.6.    Submission of Periodic Report to Health and Regulatory Authority 
Prepare and submit periodic report to both Health Authority and Regulatory Authority as per applicable law and relevant standard procedure. 

2.7.    Precursor Handling 
2.7.1.    Ensure that Precursor is handled according to compliance of all other applicable law or regulation
2.7.2.    During order processing, ensure the purchase order with specific format and separated with other products is in origin document (not a copy, scan and printed, or emailed), correct, valid, proper and reasonable.
2.7.3.    Ensure distribution of Precursor are reported monthly to Health Authority and Regulatory Authority in compliance with applicable law and relevant standard procedure.
2.7.4.    Proceed precursor disposal if needed, including requesting Health Authority’s attendance and attend the disposal process.

2.8.    Rejected product handling 
Ensure rejected or damaged product is handled as per relevant standard procedure including storage, documentation and disposal. 

3.    Training
3.1.    Identify proactively additional training needs for his/herself and warehouse personal and inform the manager to add them into the training plan
3.2.    Organize and manage information sharing, training sessions or programs related GDP activities within the warehouse 

4.    Complaint handling 
4.1.    Received complaint sample from complainant and document the handover process
4.2.    Manage storage of complaint sample once its received
4.3.    Arrange shipment of complaint sample to investigation site if needed
4.4.    Ensuring disposal of complaint sample that not being sent to investigation site 
4.5.    Support country quality head (office’s responsible pharmacist) for case registration in the Complaint Management System, log management, and monthly reconciliation with the third parties. 

5.    Quality Management System
Support country quality head (office’s responsible pharmacist) on developing, implementing, ensuring and maintaining the implementation of a quality management system including implement a process of change control and deviation, managing document system, implementation of self-inspection and product recall execution if any. 

6.    Registered Cosmetic Importation Qualified Person
Ensuring the Product Information File (PIF) of Cosmetic is available and each imported product is aligned with the PIF. 

7.    Support country quality head (office’s responsible pharmacist) on regulatory authority inspection. 

8.    Delegate his/her duties to pharmacists/pharmaceutical technical personnel who have obtained approval from the competent authority (Authorized person as per law) when he/she is not in place for a certain period of time and keep documents related to each delegation made

9.    Work as country quality head’s back up in urgent situation