Process Pharmacist
3 days ago
**Company Description**
We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.
Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.
The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.
**Role Purpose**
To ensure GDP and GWP compliance for all Warehouse and Distribution processes. Monitor adherence to guidelines, procedures and document controls. Deliver expected quality assurance and operational targets as per the business requirements. Assume pharmaceutical responsibility for warehouse processes. Serve as the deputy Responsible Pharmacist
**Main Duties**:
**WAREHOUSE OPERATIONS**
Control of Schedule 5 & 5 items
- Oversee S5 order processes and controls of stock
- Investigate and report on any S5 & S6 discrepancies
- Control all S5 Stock returns
- for all Narcotics/ Psychotropic S5 and S6 items
- Validate all S5 narcotic/psychotropic orders
- Process all S6 orders
- Balance stock and Schedule 6 registers and
- relevant S5 registers monthly according to SOP
- Cycle count S5 and S6 stock monthly and investigate any discrepancies according to SOP
- Generate SAP reports for stock movement of all Schedule 5 a& 6 items after month end according to SOP
Control of Fridge Line Items
- Ensure all fridge line items are received, stored and dispatched as required
- Ensure fridge monitoring is performed
Control of Orders requiring Permits and Data Loggers
- Verify orders to ensure no unauthorized stock leaves the warehouse
- Ensure permits are obtained and managed according to SOP and regulatory requirements
- Ensure the correct documentation accompanies the order
- Update the Export Spreadsheet
- Attach data loggers to pallet and generate relevant records and analysis
- Manage quarantine shipments
Quality Assurance
- Assist QA Manager with internal and external inspections when required
- Assist with temperature monitoring and investigations
- Ensure cleaning is conducted according to SOP
- Conduct training of staff and maintain training records
- Assist with investigation of customer Complaints
QA Stock Release
- Co-ordinate and monitor release notices, verify and approve all details are correct in accordance with relevant SOP’s
- Ensure documentation is sent to QA staff at factories and unblocking takes place
- Follow up and ensure “Urgent/Priorities” are done timeously
Blocking /Unblocking Stock
- Facilitate the unblocking of short-dated/expired stock upon request from authorized persons
- Ensure all blocking of stock is recorded with the reason and the requestor
Sample Requests
- Assist with sample requests when required
- Ensure sampling procedure meet GDP requirements
Warehouse Short-dated Stoc**k**
- Monitor and control short-dated stock within the Sealable Warehouse and printed monthly
- Draw report and submit for authorization to destroy stock within required time frames
- Ensure all BAAN transfers and the physical transfer of short-dated stock from the Sealable to a Short-dated (non-sealable) warehouse are completed
- Investigate and close out any stock discrepancies that arise in the transfer process
**STOCK RETURNS & REJECTS**
Supervise all Credit Returns Processes
- Ensure all collections and returns are processed timeously
- Ensure QA processes are followed regarding handling of stock
- Process all required stock transfers on BAAN
- Monitor the status of claim turn around and closure by warehouse
- Request / action corrections to credits raised in error
Supervise all Credit Returns Processes
- Evaluate product complaints received
- Maintain spreadsheet and trend PCR’s
- Send out communication to all relevant site
- QAM’s and designated Medical Affairs personnel
- Co-ordinate Sample requests for further evaluation by relevant QA departments, if required
- Co-ordinate “Pack for Destruction” instructions received by relevant manufacturing sites
Recall Stock
- Facilitate the return and control of all recall stock
- In conjunction with QAM determine all stock accounted for
- Finalize disposition of stock and submit required reports
Non-Conforming Stock
- Facilitate the correct investigation and reporting of all stock non-conformances
- Ensure all Suspect Stock Notification Reports are submitted to
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