Vacancies Available at Aspen Pharma Group

Responsibilities

Planning and Section Management

• Provide input into operational planning of section, and prioritization of objectives.
• Provide input into, interpret, and execute policies and procedures.
• Provide input into and manage budgets and resource requirements for section.
• Provide section staff with day-to-day direction and tasks.

QC Lab Testing

• Manage and monitor compliance of QC lab testing activities to GMP, quality standards and product specifications.
• Manage and co-ordinate lab preparation activities according to SOPs (samples, working area(s), PPE, and lab equipment.)
• Prepare and implement maintenance and calibration schedules and records.
• Ensure set priorities and targets are achieved, identifying constraints and solutions.
• Investigate and report Out Of Specifications (OOS).
• Enforce Good Lab Practice.

Environmental Management

• Manage and co-ordinate sampling and testing of external environmental, according to SOPs and sampling plan/schedule.

 Lab Quality Reviews & Training

• Validate batch documentation approvals.
• Review and approve corrections in batch documentation.
• Identify and coordinate training of staff of SOPs.

 Deviations Investigations

• Manage and coordinate deviation investigations and reporting.
• Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies.
• Manage implementation of operational changes to SOPs and processes.

Governance, Risk and Compliance

• Provide input to QC for improvement of risk-based compliance systems.
• Monitor implementation and correct own and / team compliance with legislation, policies and procedures.

Requirements

Background/experience

• Bachelor’s degree in chemistry / microbiology with 5 years of related experience.
• Laboratory and Good Laboratory Practice experience.
• Supervisory experience.

 Specific job skills 

• Advanced understanding of pharmaceutical testing methods.
• Knowledge of value chain and MCC principles.
• Understanding of pharmaceutical manufacturing and corrective action programs.
• Pharmaceutical standards and compliance requirements.
• Ability to interpret and implement policies, processes, and objectives.

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JOB REQUIREMENTS: 

• Minimum educational qualification Matric /Grade 12 with mathematics and Science/Biology.
• Must have an aptitude for process understanding and work with your hands.
• Must have the ability to be trained and of good health.
• Previous process operator experience in a manufacturing plant would be advantageous but not a requirement.
• Form part of the emergency response team (i.e., firefighter, first aider, evacuation warden, or H&S representative).

BASIC JOB FUNCTIONS:            

• To become conversant in the operation of production equipment/machines according to set procedures and work instructions.
• Understand and comply with all relevant SOP’s and work instructions.
• To follow instructions as guided by either Team Leader or Supervisor.
• Performs regular housekeeping duties to ensure a clean and healthy work environment according to current good manufacturing practices (cGMP) requirements.
• Understand and comply with relevant health, safety, and environmental procedures whilst performing his/her duties.
• Participate in driving production performance (KPIs).
• Drive operational excellence in production.
• Responsible for running the manufacturing process centre in line with cGMP and QMS.

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Responsibilities

Operational Activities

•  Optimize all packing processes within SVP by validating, qualifying, and testing machines, and investigating quality concerns.
• Lead investigations, ensure corrective action is taken and provide support as required.
• Project manage new equipment projects and all associated activities from inception to close-out.
• Track performance against budget.
• Coordinate and oversee activities of all cross functional departments.
• Manage supplier technical relationships.
• Adherence to Standards
• Comply with all GMP/GLP standards and regulations.
• Identify, manage, eliminate or mitigate any hazard or potential hazards.

Planning and Processes

• Provide technical and operational input when drafting plans.

Asset/Resource Management

• Determine resource needs of the team and/ or own area of work.

Technical/Functional Experience

• Apply advanced understanding of discipline / specialization.
• Analyse concepts and prepare procedures to operationalize new ideas.

Reporting / Reporting & Record Keeping

• Provide information for reports on weekly/monthly basis.
• Compile standardized reports and consolidate documents.

Supervision

• Provide staff with day-to-day direction and tasks.

Skills Required

Background/experience

• 4-6 years’ experience in a high speed multi format packing line manufacturing environment
• BSc Engineering or alternative degree in Pharmacy or Science
• Specific job skills

Project management

• Process, mechanical, electrical and electronic engineering skills.