Job Description

Overview

• Ensure risk-based containment, exposure monitoring related to API & HPAPI exposure for all work conducted in SA Operations.

Responsibilities

API project management * Be a member of all project teams (construction, tech-transfer etc.) and advise on containment performance requirements for the design.

• Assist with the management of project- close out and structure/facility/equipment commissioning.
• Manage the Containment monitoring programme and SMEPAC.

Measuring & monitoring - Containment monitoring * Evaluate and assign health-based exposure limits for active pharmaceutical ingredients (APIs) and hazardous chemical and biological agents (OEL, ADE, ASL)

• Evaluate and assign environmental limits for active pharmaceutical ingredients (APIs) and hazardous chemical and biological agents (PNEC, PEC)
• Assessment of introduction of new products on waste handling requirements - impact on effluent / PNEC /PEC
• Impact of changing product volumes and product mix on waste / effluent / ADE / PEC
• Conduct time-studies for risk-operations and assist with risk calculation; advise on additional containment measures and quantity.
• Co-ordinate HCA and HBA H&S and cGMP-hygiene surveys.
• Coordinate environmental monitoring regarding API & HPAPI wastewater & formulate risk-based containment measures.
• Analyse the environmental risks and formulate containment for waste, effluent; advise on the dynamics of the Wastewater plant.
• Assist the health care centre in developing surveillance programs to track the effects of hazardous exposures.

Risk Assessments * Perform health and safety risk assessments of occupational hazards emanating from APIs, HCAs and HBAs

• Perform environment impact assessments of environmental aspects emanating from APIs, HCAs and HBAs
• Develop standardized health-based risk assessment methodologies and models for performing risk assessments of contaminant exposure via air, surfaces and wastewater.
• Assist in risk assessments to develop programs designed to prevent environmental and occupational exposure to hazardous materials and conditions.
• Risk assessment of change in working conditions - related to working hours changing - assess impact of ADE/PDE and related operations in areas -PPE requirements/working or exposure times.

Incident investigations * Investigate breaches of containment.

Operational Controls * Budget for and manage Monographs and SDS if required.

• Liaise with Capability regarding HCA and HBA training.
• Manage the processes of Chemical Toxicology (CT) (e.g., request processes; reporting to key customers, outsourcing activities when warranted, and managing CT database).
• Support to Cleaning Validation Team for creation of ADE / OEL / Surface Level Assessments.

Policies & legal requirements * Create, edit and review of procedures, work instructions and standard forms in conjunction with interested and affected parties

• Evaluate and interpret the toxicologic literature concerning hazardous materials.

Reporting & record keeping * Member of each project team dealing with hazards or containment of APIs, HCAs, HBAs

• Provide information for completion of reports
• Manage monograph acquisition, importation and internal approval, archiving and review; Ensure that the monograph is signed off, updated & on VEEVA
• Complete and consolidate standard documents
• Maintain and update records, systems and portals as required
• Maintain API/HPAPI inventory
• Include new monograph details and amend existing data when monographs are revised.
• Compile relevant documents for communication of health-based exposure limits and related training

SHE & GMP performance * Conduct trend analysis for performance indicators

• Co-ordinate and document Objectives/ CI initiatives for site.
• Conduct standard training, as required.
• Sign off survey reports and co-ordinate corrective and preventative actions

Background/experience

• M.Sc. or Bachelors degree in Toxicology, Pharmacology, Biology, Chemistry, or similar is required.
• Experience in Occupational and product toxicology is required, pharmaceutical manufacturing, and OEL/OEB/PDE development is preferred.

Specific job skills * Risk assessment.

Competencies * Good communication skills, likes to work in teams, learning agility, IT skills (Microsoft Office package), scientific literature tools, virtual meetings.

• Familiar with SharePoint, SAP, and/or other databases, IT affinity.
• Able to perform detailed work with limited oversight on concurrent tasks.

Accountability & Decision Rights * Apply advanced and mastered knowledge of concepts, methods, terminology, codes, quality standards and specialised job requirements.

• Provide updates to management regarding team or operational performance, work progress and quality.
• Serve as a technical advisor to management to resolve the most complex technical challenges, and handling escalated issues as a lead technical expert.
• Escalate out-of-policy matters.

Independent decisions relating to: * Non-routine issues.

• Correction and/ or containment of errors of significant impact (financial loss, customer business, materials and/ or equipment downtime).
• Prioritisation of tasks and responsibilities within overall direction and clearly defined parameters/ schedules and established policies, practices, guidelines, and quality and safety checks.

Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

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Aspen Pharmacare