QA Manager & Responsible Pharmacist at Aspen Pharma Group

Purpose of Position:
To implement and maintain a Quality Management System compliant with GMP/GDP/GWP requirements. To ensure compliance of the warehouse to pharmaceutical requirement as stipulated by the MHRA/MCC of SA.

Requirements

• B Pharm or equivalent
• GDP Certificate and 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 GMP and GDP ISO 9000
• Computer Literate
• Training skills
   

Key Responsibilities

• 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 MCC & SAPC
• Liaise with Aspen QA Managers relating to quality issues
• 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 SOP's to ensure effectiveness
• Ensure training of quality procedures for site
• Ensure training of desired level of GMP/GDP/GWP
• Develop and train own staff
• Ensure availabil ity 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
• Review processes to ensure compliance for audits
• Ensure compliance to procedures, GMP/ GDP/ GWP and regulatory
• Monitor temperature and humidity; analyses data and compile reports
• Ensure Non-conformances are recorded, investigated and corrective action implemented
• 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
• 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 SLA's 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 are clearly addressed
• 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
• Compile AnnualInternational Narcotics Control Board Report for submission to the Department of Health (DOH)
• Oversee compilation of monthly reports on Export permits / Schedule 5 & 6 medications
• Assist Manufacturer/ Applicant/Holder of Certificate of Registration with recall process
• Oversee training for site both internal and external
• OverseeInduction and SOP training
• Oversee SOP training
• Oversee training profiles for employees
• 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
   

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