API Manufacturing Specialist

5 days ago


Singapore AMARIS CONSULTING PTE. LTD. Full time
About Amaris Consulting
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With over 1000 clients across the globe, we have been delivering solutions in major projects for over a decade – this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries.

Salary Estimate
The estimated salary range for this role is between $80,000 and $120,000 per year, based on industry standards and location considerations.

Job Description
Main Responsibilities
  • 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.

Required Skills and Qualifications
  • 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.

Benefits and Opportunities
  • Professional Development: Opportunities for growth and professional development in a dynamic and innovative environment.
  • Diverse Projects: Work on diverse projects and contribute to the success of various clients and industries.
  • Collaborative Team: Join a collaborative team of professionals who share your passion for excellence and innovation.


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