QA Compliance Pharmacist at Aspen Pharma Group

Description

Overview

To perform pharmaceutical tasks within the Vendor Management sub-department of the QA department. This entails 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.

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