Job Description

Job Objective:

• Execute process and product in line with regulatory requirements and contribute to the Device Master Record (DMR) by compilation of product development and manufacturing documentation.
• Equipment qualification.
• Establish product ageing regimes and analyse data generated from these stability trials.

Minimum Job Requirements:

• Bachelorxc3xa2xc2x80xc2x99s Degree Industrial/Process Engineering.
• Min 3 to 5 years working experience in a production environment pref. within a medical / pharmaceutical environment.

The Job:
Reporting to the Initiative Manager:

• Plan and co-ordinate trials in accordance with business requirements:

• Production trials on new or existing products/packaging in the factories.
• Process or product validations on new or existing products/packaging in the factories.
• Co-ordinate assigned projects in accordance with company policies/regulatory requirements.
• Compile and execute qualification protocols and reports (SLIA, IQ/OQ).
• Execute performance qualification.
• Establish/compile stability protocols/report.
• Create new versions R&D technical and manufacturing documents (DIOS, UOUP, DMR, IPRS, PMCC, etc,).
• Compile cost estimates and feasibility studies of projects/products.

Competencies:

• Accuracy of work (documentation, cost estimates).
• Meeting project deadlines.
• Proficiency in Microsoft packages, specifically Excel, Word, PowerPoint.
• Excellent problem-solving skills.
• Excellent verbal and written communication skills.
• Must be innovative.
• Must be able to work under pressure.
• Must be a team player and collaborative.
• Show commitment to the task at hand.
• Courage to innovate.

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