Authority, Responsibility, Duties & Competence Requirements

Job Purpose: To ensure total compliance of the department to pharmaceutical GMP standards and support production activities from a pharmaceutical perspective.

Responsibilities /Duties:

Responsible for the assessment of production processes in order to establish level of compliance versus pharmaceutical standards.

Promotion of GMP Compliance within the department.

Conduct product anomaly investigations and complete CAPA actions report to prevent re-occurrence of anomaly incident. Ensuring timeous close-out of events/deviations,

CAPAs and change controls.

Responsible for the recipe creation, implementation and recipe maintenance.

Performs departmental internal audits to establish level of compliance and necessary corrective actions to close gaps identified.

Participates in external departmental audits and the completion of the subsequent audit finding report.

Conduct ad hoc product studies or trials as part of process improvement initiatives.

Participates in writing, reviewing and updating departmental Standard Operating Procedures.

Coordinate/Conduct training initiatives within the department to ensure that all staff is properly trained and competent to perform their job function.

Responsible for the identification of process improvement opportunities in order to prevent product loss and unnecessary product discard.

To take on mentoring role for pharmaceutical staff.

Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack

Job Title Senior Production Pharmacist

Occasionally perform duties of Production Pharmacist as follows:

Ensures that his/her supervisors/team leaders are conversant with daily production program and organizes the department's activities accordingly.

Identifies and addresses daily production problems

Reports / liaises daily with the Department Manager on the production situation.

Performs department pharmaceutical duties.

Is responsible for department productivity and loss control (labour, money, machines)

Ensures that the daily production program and targets are met.

Carries out 'second line' management function for staff problems/disputes.

Responsible for the department compliance with factory rules and regulations.

Responsible for the accurate completion and reconciliation of departmental batch book documents

From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Competence / Requirements:

Understand LVP production processes

GMP Principles

Understand quality investigation requirements (risk assessments, deviations, change controls ie. Kabitrack)

Root Cause Analysis

Ability to write, review and update SOPs

Recipe creation

Auditing and audit preparation

Industrial Relations

Understand Continuous Improvement Techniques

Understand batch book requirements

Health and Safety compliance

Cleanroom gowning competency SOP

Performance Measurement

According to KPI defined through the annual performance management process

Qualification and Experience Requirements

B Pharm Tertiary qualification

Registered Pharmacist with South African Pharmacy Council

A minimum of 3 years pharmaceutical manufacturing experience is essential.

Specific Large Volume Parenteral process technical knowledge/skills are advantageous.

Proven 'hands – on' managerial ability

Production management skills

Human resources / industrial relations skills

N.O.S.A awareness