QA Compliance Pharmacist

2 weeks ago

Johannesburg, South Africa Aspen Pharma Group Full time

**Overview**

To perform pharmaceutical tasks within the Vendor Management sub-department of the QA department. This entails the management of vendors, Technical Agreements and associated functions as per GxP and company Standard Operating Procedures.

**Responsibilities**:
**General Operational Activities**
- Execute daily tasks and work instructions according to the relevant SOP's.
- Operate computer systems by capturing data, printing standard reports, etc.
- Perform reconciliations of data
- Update and maintain databases
- Generate reports as per instruction
- Verify and interpret the accuracy of data and audit documentation
- Ensure that all relevant documentation gains the necessary signatures for completion
- Maintain accurate filing and retrieval of documentation
- Perform any other administrative tasks relating to your work as and when required.

**Management of Vendor Audits**
- Manage vendor audit schedules
- Conduct vendor audits
- Compile Audit Reports
- Document Audits on Trackwise system
- Ensure appropriate CAPAs from audit findings are tracked and followed through to completion.
- Perform Desktop Audits, when required as per SOP.
- Ensure risk assessment of all vendors is conducted and audits are planned according to this risk categorization.
- Periodically request information from vendors regarding recent regulatory inspections of their company, review this information and determine risk (if any) to the service provided to Aspen and its product.

**Management of Technical Agreements, manufacturing licences and GMP certificates**
- Draw up Technical Agreements (TA’s) with new vendors/affiliates to ensure that all the quality requirements of both parties are stipulated and both agree to comply with it.
- Ensure active TA’s are being reviewed and updated according to their review dates.
- Perform a gap analysis to determine vendors who do not have TA’s in place and formulate a plan to close the gap.
- Compile and maintain a database of all vendors for Pharmacare Ltd containing all the relevant information to assist in audits and Technical Agreement (TA) management.
- Ensure that the TA SOP, template and associated documents are current, effective on DocCompliance and being reviewed when required.
- Compile TA declaration for RA department for new submission and amendments.
- Management of Manufacturing licenses and GMP certificates of all Aspen Pharmacare vendors.

**Reporting and Quality Systems**
- Compiling Monthly Departmental Report
- Providing vendor management information for QSMR reports.
- Compiling AD-hoc reports as required
- Compiling and reviewing of SOP’s and related standard forms related to work function.
- Completing of Change control action items related to vendor management.

**Management of Distribution Quality and Customer Relationship**
- Managing the quality relationship between Aspen and distributors and providing guidance on QA matters and decisions.
- Managing short-dated stock release process
- Managing of the co-marketing arrangements with distributors, e.g. GSK products.
- Managing of Blocked stock notifications.

**Continuous Improvement**
- Identifying gaps within the current process and investigating and proposing ways to close the gaps.
- Identifying ways to streamline the processes, resulting in greater efficiency and productivity.
- Ensuring the necessary information and statistics generated by the department is accurate and easily retrievable.

**Health, Safety and Environmental Standard**
- Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
- Report any unsafe or unhealthy situations to SHE representative or Line Manager
- Report any incident to the SHE representative or Line Manager which may affect your health or cause injury.

**Job Requirements**

**Background/experience**
- Matric/Grade 12
- Bachelor in Pharmacy
- Registration with South African Pharmacy Council (SAPC)

**Specific job skills**
- Computer literacy, including proficiency in the use of MS Excel and MS Word
- Sound knowledge of GxP; Good Manufacturing Practice, Good Distribution and Wholesale Practice, Good Documentation Practices, etc.

**Competencies**
- Good verbal and written communication skills
- Professional presentation
- Time Management
- Ability to multi task and strong proven follow-up skills is a requirement
- Planning and organizing skills
- Good interpersonal skills
- Good negotiation skills
- Good decision making skills

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