Key Responsibilities

1. Manufacturing Support and Process Improvement

• Provide day-to-day technical support to Production for formulation, raw-material, equipment-interaction and process issues.
• Troubleshoot batch and process problems and recommend practical, risk-based solutions that support product quality, consistency, yield and efficiency.
• Review batch records, manufacturing data and test results to identify variation, trends and improvement opportunities.
• Implement approved process improvements and assess their effectiveness using manufacturing and quality data.

2. Investigations, CAPA and Change Control

• Lead or support investigations into nonconforming product, raw materials, formulations, equipment and manufacturing processes.
• Apply structured root cause analysis and risk assessment using manufacturing history, testing and technical evidence.
• Develop corrective and preventive actions, including suitable effectiveness checks where required.
• Prepare and progress change controls for raw materials, suppliers, formulations, equipment, processes, specifications and manufacturing documents within agreed timelines.

3. Validation and Manufacturing Trials

• Plan and execute assigned manufacturing trials, process validations and equipment qualification activities with Production and Quality.
• Prepare fit-for-purpose protocols, trial plans, risk assessments, data evaluations and reports.
• Support formulation scale-up, process transfer and introduction of new or modified products, materials and processes into manufacturing.
• Review trial and validation outcomes, identify risks and recommend follow-up actions or improvements.

4. Documentation, Compliance and Training

• Prepare and maintain manufacturing procedures, work instructions, master manufacturing documents, troubleshooting guides and technical reports.
• Maintain accurate and traceable records for investigations, CAPAs, change controls, validations and trials.
• Work in accordance with GMP, good documentation practices, workplace safety requirements and the SDI Quality Management System.
• Provide technical input to audits and inspections, and deliver knowledge transfer for new or revised materials, formulations, equipment and processes.

Key Relationships

Internal

Production; Quality Assurance; Quality Control; Research & Development; Supply Chain and Planning; Engineering; Regulatory Affairs

External

Raw-material and equipment suppliers; contractors; laboratories; technical service providers

Qualifications, Experience and Skills

• Bachelor's degree in Chemistry, Applied Chemistry, Chemical Engineering, Pharmaceutical Science or a related scientific discipline.
• Minimum two years of relevant experience in manufacturing, process chemistry, pharmaceuticals, medical devices or another regulated industry.
• Hands-on experience supporting chemical or formulation-based manufacturing and troubleshooting process issues.
• Experience with investigations, root cause analysis, risk assessment, CAPA, change control and controlled technical documentation.
• Sound applied chemistry knowledge relating to formulations, raw materials, mixing, processing behaviour and finished-product performance.
• Working knowledge of GMP, good documentation practices and quality management systems.
• Strong analytical, problem-solving, data-interpretation and written communication skills.
• Ability to manage competing priorities, work independently with appropriate guidance and collaborate across functions.
• Competence in Microsoft Excel and Word.