Ensure risk-based containment, exposure monitoring related to API & HPAPI exposure for all work conducted in SA Operations.
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 xe2x80x93 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.
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 xe2x80x93 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.
Skills Required
Background/experience
M.Sc. University degree in Toxicology, Pharmacology, Biology, Chemistry, or similar is required.
PhD Toxicology, Pharmacology, Biology, Chemistry, or similar is preferred.
Advanced years of 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.