QA Manager & Responsible Pharmacist – EDC (East London) at Aspen Pharma Group

Purpose of Position

• To Implement and maintain a Quality Management System compliant with GDP/GWP requirements. To ensure compliance of the warehouse to pharmaceutical requirement as stipulated by SAHPRA.

Key Responsibilities

OPERATIONAL ACTIVITIES:

• Follow and resolve all distribution quality queries in the shortest possible timeframe within policy framework.
• Display a professional attitude when responding to customer’s needs.
• Propose and continuously develop methods to improve customer services.
• Respond to distribution quality-related complaints and liaise with customer and regulatory affairs.
• Interact with SAHPRA & SAPC.
• Liaise with Aspen QA Managers relating to quality issues

QUALITY MANAGEMENT SYSTEMS

• Ensure that site is informed and aware of the Quality policies.
• Direct and manage the Quality Management System.
• Monitor key performance areas relating to quality.
• Establish quality plans for the warehouse.
• Generate, maintain, monitor and review SOPs to ensure effectiveness.
• Ensure training of quality procedures for site
• Ensure training of desired level of GDP/GWP
• Develop and train own staff
• Ensure availability of training records for inspection
• Direct and manage implementation of applicable quality standards
• Monitor VMP, review and authorize VMP
• Monitor and review calibration and validation status of equipment
• Ensure effective Change Control and Deviations control and management system is in place.

MONITORING AND MEASUREMENT

• Review processes to ensure compliance for audits
• Ensure compliance to procedures, GDP/ GWP and regulatory requirements.
• Monitor temperature and humidity, analyses data and compile reports
• Ensure Non-conformances are recorded, investigated and corrective action implemented 

AUDITING

• Plan internal audits
• Conduct internal audits – ongoing
• Write reports and follow up on corrective actions
• Feedback to senior management
• Facilitate Vendor audits as when required
• Compliance to procedures, GMP/GDP/GWP and regulatory requirements

REGULATORY

• Compile and maintain site master file
• Review and inspect for regulatory compliance
• Familiarize with PIC, FDA and MHRA / MCC standards
• Ensure compliance to regulations for relevant markets
• Report to Distribution Manager regarding operational requirements
• Maintain relevant delegation letters
• Maintain licenses for premises and personnel to MCC, SAPC and DOH
• Ensure SLAs are in place with relevant
• Service Providers
• Review and maintain Technical Agreements/SLA’s to ensure quality matters relating to warehousing/distribution of pharmaceutical goods is clearly addressed

STOCK CONTROL

• Stock losses should be minimized by implementation of appropriate security measures
• Monitor stock discrepancies by reviewing inventory adjustments performed and cycle count results 
• Report on stock losses using internal reporting structures, and when required, the relevant regulatory authorities. 
• Compile Annual International Narcotics Control Board Report for submission to the Department of Health (DOH)
• Oversee compilation of monthly reports on Export permits / Schedule 5 & 6 medications

RECALLS

• Assist Manufacturer/ Applicant/Holder of Certificate of Registration with recall process

TRAINING

• Oversee training for site both internal and external
• Oversee Induction and SOP training
• Oversee SOP training
• Oversee training profiles for employees

GENERAL

• Ensure compliance with SHE requirement
• Ensure that Health and Safety procedures are adhered to, and correct PPE are used
• Repair and maintenance of equipment and facilities

MANAGEMENT

• Manage departmental financial, SHE, HR and GMP responsibilities and activities
• Plan, lead, allocate and manage departmental activities, resources, and tasks in accordance with agreed budgets, service/delivery targets and daily/weekly/monthly plans
• Establish and maintain appropriate systems for operational management and measurement
• Develop and implement continuous improvement plans and actions
• Manage departmental absenteeism

  FINANCIAL

• Set Annual Budgets and Quarterly Forecasts
• Meet output requirements, while containing expenditure
• Meet targets on yields and write offs
• Ensure capital expenditure plans are met
• Ensure control and approval of expenses in accordance with the company approvals framework
• Control all inventory in area of responsibility
• Ensure annual stock stakes meet control requirements

HUMAN RESOURCES / PEOPLE

• Promote diversity, equal opportunity and fair treatment in the workplace
• Execute company EE plan, procedures and targets
• Formulate and execute a Workplace Skills Plan in conjunction with the HR Department
• Manage staff performance through the Company Performance Management program
• Manage staff succession through the company succession planning program

GDP/GWP

• Comply with GMP/GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities
• Ensure that products stored according to the required SOP’s and documentation
• Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation.
• Ensure that the required resources, systems and SOPs are reviewed, authorized and are regularly monitored, adapted and improved to ensure compliance to GDP/ GWP regulations/standards and the product license
• Ensure that environment (facilities and equipment) is maintained to GDP standards
• Ensure that the initial and continuing departmental personnel training is carried out and recorded
• Ensure that records are evaluated and corrected before they are sent to the Quality Department
• Investigate and initiate corrective actions for all quality deficiencies

Health, Safety and Environmental Standards

• Carry out any duty or requirement imposed on the company by the OHS Act and in accordance with your specific SHE appointment
• Ensure that all employees are informed of their scope of authority as contemplated in the OHS Act
• Take full responsibility and necessary measures to ensure that the requirements of the OHS Act are complied with by every person in your employment or on premises under your control where plant and machinery are produced
• Ensure that reasonably practicable steps are taken to identify, manage, eliminate or mitigate any hazard or potential hazards to the safety or health of employees, attached to any work performed, any article or substance produced, processed, used, handled, stored or transported and any plant, machinery which is stored or transported
• 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

Key Behavioral Dimensions and skills:

• Strongly motivated to provide service to customers
• Motivated, flexible and able to work within a team-orientated environment
• Logical thinking and information seeking
• Ability to follow and issue instructions
• Planning, organizing and communication skills
• Meticulous attention to detail

Requirements:

• B Pharm or equivalent
• GDP Certificate an advantage
• Current registration with Pharmacy Council
• Minimum 2 years Quality Assurance Management and systems experience
• Minimum 2 years’ experience as a Responsible Pharmacist
• 5 years’ experience as a Pharmacist in a distribution environment
• Thorough understanding of GDP/GWP