New Vacancies at Aspen Pharma Group

JOB REQUIREMENTS:

• Degree in Chemistry/Chemical Engineering or equivalent qualification.
• Good knowledge of chemistry (Analytical and Organic).  Statistical knowledge would be advantageous.
• Minimum of 1 year experience in pharmaceutical, cGMP or chemical manufacturing environment.
• Proven technical documentation compilation skills, with the ability to critically evaluate and interpret data.
• MS Office computer literacy, particularly the following applications: Word, Excel, Outlook, Teams, Access and PowerPoint.  Minitab and/or EXTEDO proficiency would be advantageous.

 JOB FUNCTIONS (Brief Summary)

• Compilation and/or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations.
• Performing risk assessments to evaluate the potential presence of elemental, genotoxic and/or nitrosamine impurities according to relevant regulatory guidelines.
• Compilation of process qualification protocols and reports.
• Investigating, evaluating and reporting on process performance and proposed changes.
• Ensuring that annual product quality reviews are compiled according to cGMP standards and adverse trends and potential process improvements identified.
• Implementing changes according to established company procedures relating to the testing and manufacturing process.
• Compilation and update of documents to be submitted to Regulatory Authorities.  This includes compilation of Common Technical Documents.
• Ensuring that related databases are updated to allow for the capturing of API data.

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KEY PERFORMANCE AREAS

Core Legal Work:

• Specialised Aspen and Business Unit (“BU”) aligned general legal work in the Legal Team under guidance of the responsible Aspen Lawyer

Paralegal Expertise:

• Efficient and accurate paralegal expertise including drafting, first comments, file management, project and matter co-ordination, management of deliverables and reporting

Legal Management Administration:

• Efficient and accurate Legal practice management, electronic file creation and management, electronic document retention, contract management via the electronic Aspen Contract Library (ACL), electronic reporting and certain general administration including processing invoices

Cross Swimlane Projects:

• Meaningfully contribute and deliver ancillary legal work in Group Legal cross – swim lane projects, as allocated by the Group Executive: Legal

BU Allocated Responsibility:

• Group Legal BU Allocated Responsibility, including:
• Template creation, improvement and management
• From time-to-time BU administration allocated by the Group Executive: Legal

Group Legal BU KPI:

• Meet (or exceed) and manage Group Legal BU KPI

Aspen Values & personal Insights:

• Adopt and comply with the ways of working within the Aspen Group Legal BU, including specifically the Aspen Values and honest application of personal Insights® Profile (or similar from an Aspen Group service provider) to enhance interpersonal effectiveness

JOB REQUIREMENTS

EDUCATIONAL QUALIFICATIONS & EXPERIENCE:

• Matric / Grade 12 and recognised professional paralegal qualification, or university degree or sound progress towards a university degree, which is preferable
• Registration with appropriate qualification body
• 3-5 years demonstrated experience in performing a senior legal secretary and or paralegal function, some of which has ideally been at an in-house legal department

SPECIFIC EXPERIENCE, KNOWLEDGE AND REGISTRATIONS:

• Exposure to working with long, complex legal agreements essential
• Familiarity with legal terminology essential
• Relevant experience in a legal practice or corporate environment essential
• General commercial understanding and exposure
• Advanced legal sense; systems; pharma product knowledge and industry understanding an advantage

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JOB REQUIREMENTS:

• Must have a Chemistry or Chemical Engineering tertiary degree in accordance with the National Qualifications Framework (NQF).
• Must have 5 years of manufacturing experience with at least 2 or 3 years of Supervisory experience.
• Good working knowledge of cGMP (current Good Manufacturing Practice) pertaining to the manufacture of Active Pharmaceutical ingredients (API’s).
• Must have good working knowledge and understanding of the OHSE Act and Regulations.
• Good knowledge, understanding, and experience of chemistry and chemical processes.
• Must be computer literate and competent with Microsoft Office. SAP would be advantageous.
• Must be able to write reports.
• Must be able to interpret and implement policies, processes, and objectives.

JOB FUNCTIONS (Brief Summary):

• Manage and supervise the operational activities of API manufacturing according to a production plan and in accordance with the applicable Quality Management System requirements.
• Ensures that the product produced in the production facility conforms to the relevant quality and standards as they relate to customer criteria, GMP, and OHSE matters.
• Optimize systems, processes, and procedures and ensure that plant resources are utilized effectively and efficiently.
• Plan, lead, allocate, and manage departmental activities, resources, and tasks in accordance with agreed budgets, service delivery targets, and daily, weekly, and monthly plans.
• Establish and maintain appropriate systems for operational management and measurement.
• Manage departmental absenteeism.
• Ensure GMP and GDP compliance of Production operations.
• Adhere to all Company OHSE rules and regulations.
• Related administrative tasks.
• Consistent execution of objectives, holding staff accountable to established policies.
• Deliver operational efficiencies and reduce unplanned downtime.
• Equip staff with the knowledge, practical skills, and motivation to carry out their work activities effectively.