The Responsible Pharmacist will be responsible for some or all of the following activities, to be divided based on department needs and must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

Key Responsibilities

• Maintain the Site Master File and ensure compliancy to regulation guidelines set out by the South African Health Products Regulatory Authority (SAHPRA) and South Africa Pharmaceutical Council (SAPC)

• Delivering high standards of pharmaceutical care for the end-to-end management of dispensary operations in accordance with Good Pharmacy Practice and Good Wholesale Practice
• Maintain pharmacy plans, Standard Operating Procedures (SOP’s) and other relevant documentation required by law.
• Overall control within the guidelines for warehouse as per Pharmacy Council specifications
• Participate in and contribute to the development and achievement of the corporate goals and objectives
• Registrations and Licenses – SAHPRA, SAPC and Dept of Health:
• Annual Fees, Inspections and Responses and Communications.
• Overall compliance with the Laws and Regulations.
• Identify regulatory and quality training needs, and delivering training
• Leads liaison with regulatory bodies

Key Duties (Operational)

• To dispense study related drugs according to project specific protocols and SOPs
• Oversee coordination of logistics activities by ensuring clinical supplies are receipted, stored and distributed in accordance with Fisher Clinical Services approved procedures and policies, cGMP, cGDP, and regulatory requirements.
• Manage and control returns, quarantine, destruction, expired stock and batch recalls
• To liase with the QA Manager for the implementation of changes to pharmacy plans, SOPs and other relevant documentation
• To monitor drug storage conditions and record keeping
• To monitor 100% drug accountability and compliance with randomisation codes as per study specific procedures
• Ensure that required environmental conditions are continually met
• Perfom departamental self inspections
• Participate and follow up on actions from monthly quality control monitoring
• Participate in study-related training

• Assist in the investigation of internal and external non conformances through to resolution where required
• Assist in the investigation of customer complaints through to resolution where required
• Liaise closely with clients on return drugs & destruction.
• Assist in internal audits according to SOP requirement and assist in regulatory, supplier and client audits.
• Lead / Participate in recalls when needed
• Assist in the QA/GMP training of employees across the company
• Provide leadership, training and career development for all subordinates
• Design KPI reports to monitor daily and monthly performance.
• Contribute in weekly and monthly management meetings.
• Design a structure that can provide high standards of service.

Other

• Perform any reasonable task, in line with the business’s goals, as requested by upward liaison on projects and improvement initiatives as required by Management
• Participate in ad hoc assignments
• Perform other duties that are commensurate with the job
• Manage and plan daily duties and tasks

Key Performance Metrics in line with PMD

• Provide operational excellence in area’s of responsibility
• Ensure a 100% achievement in area of responsibility for all internal/external QA audits

Education

• Grade 12 / Metric.
• (BPharm) degree

Working Experience

• Minimum of 5 years practical experience working within a Pharmaceutical environment.
• Knowledge of SAHPRA & SAPC regulations/guidelines
• In depth knowledge of legislation pertaining to the pharmaceutical industry and understanding of functions and responsibilities of a Responsible Pharmacist as per the medicines act, pharmacy act and cGMP Guidelines.

Software Skills:

• Proficient to Advanced Microsoft office skills. Excel, Word, Power Point. GPM .

Other skills

• Ability to work under pressure and to support others within the team.
• Excellent written and verbal communication, computer, analytical problem solving, planning/organizational, interpersonal/teamwork, negotiation and leadership skills are necessary.
• Extensive spreadsheet analysis and strong mathematical abilities
• Ability to co-ordinate various processes simultaneously
• Detail oriented with extreme accuracy
• Ability to work cross-functionally.

Attributes

• Planning
• Problem solving
• Follow up
• Time management
• Good communication skills
• Initiative
• Customer service
• Telephone etiquette
• Financial orientation

Key Responsibilities & Accountabilities (Tasks & Deliverables):

• Drive day to day service improvements for supply from Inter-company affiliates and 3rd party suppliers.

Work Schedule:

07h30 AM to 16h30 PM core hours, additional hours as required. __5_% travel