Electronic Batch Records: Set up and manage electronic batch records for manufacturing processes.
Process Improvement: Lead technical support and improvement initiatives to enhance ongoing manufacturing operations.
Start-Up and Validation: Assist in the start-up, validation, and qualification of plant equipment and facilities.
New Product Introduction: Support manufacturing activities during technology transfer, qualification, and validation batches for new products.
Operational Efficiency: Contribute to achieving operational efficiency goals, including yield, product quality, and other key performance indicators (KPIs).
Troubleshooting: Serve as a contact and consultant for process and equipment troubleshooting and investigations.
Risk Assessment: Provide technical expertise for risk assessment activities.
Cleaning and Changeover: Support process cleaning and changeover strategies.
Documentation: Author and maintain technical reports, batch records, standard operating procedures (SOPs), investigations, and protocols, ensuring consistency and quality.
Skills and Competencies
Technical Expertise: Strong knowledge of API manufacturing processes and equipment.
Problem-Solving: Ability to quickly identify and resolve operational issues.
Process Improvement: Experience in leading process improvement initiatives.
Documentation: Proficient in authoring and maintaining technical documentation.
Communication: Excellent communication skills for effective collaboration with cross-functional teams.
Attention to Detail: Strong attention to detail to ensure accuracy and quality in all tasks.
