QS Pharmacist

QS Pharmacist
Aspen Pharma Group
2023-07-05 Port Elizabeth

Job Ref #: QSPharm12
Industry: Manufacturing
Job Type: Permanent
Positions Available: 1

Applications are invited for the above indicated vacancy that exists in the Quality Systems departmentin Gqeberha. The successful incumbent will report to the Quality Systems Manager. All applications are to be received on or before 12 July 2023. Preference will be given to Employment Equity candidates in line with Aspen’s Transformation Agenda.

Job Description

Overview

• Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES

• Coordinates and supports administrative functions within QS

Responsibilities

QS coordination and support

• Provide QA IT systems support

• Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements

• Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions

Master data management

• Define and manage critical data relating to quality

• Ensure adherence to product master data standards Master batch record (MBR) creation and validation

• Create new item IDs on the ERP

• Create and maintain precise, detailed and compliant manufacturing instruction/ description documentation on the system

• Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)

• Ensure that MBRs are GMP compliant

Ensure proper MBR change controls in process compliance Procedure and document compliance

• Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares

• Implement quality manuals and policies

• Conceptualise, initiate and author SOPs and process documents Identify, process and store records and review output documents

• Conduct reviews of protocols for product launches Audits and reporting

• Conduct root cause analysis and risk assessments and report

• Participate in QMS monthly and annual reviews

• Conduct and report on statutory external (regulatory) audits Planning and operational support

• Provide technical and operational input during drafting of quality plans and procedures specific to unit

• Request, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectives

• Stay up to date on developments, trends, legislation and regulations

• Provide information for reports, as required by superior

Job Requirements

Requirements Background/experience

• Bachelor’s degree (B Pharm) with 4-6 years’ related work experience

• Pharmaceutical manufacturing experience

• Extensive experience working with compliance procedures and administrative process automation Specific job skills

• Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA 

Advanced understanding of the pharmaceutical manufacturing and corrective action programs

• Pharmaceutical standards and compliance requirements

• Excellent computer/ IT system administration skills Competencies

• Information Gathering

• Interrogating Information

• Offering Insights

• Endorsing Quality Standards Accountability and Decision Rights

• Demonstrate initiative and apply advanced concepts

• Exercise interpersonal, communication, training and problem solving skills to optimise team performance integrate resources for an area

• Escalate highly complex problems or out-of-policy issues Decisions relating to:

• Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training/ education

• Establishing own work priorities and timelines Interpretation of policies, standards, requirements and approaches