- Support New Product Introduction (NPI) and existing products by actively participating in validation, qualification activities, and quality investigations.
- Author technical or validation protocols, reports, and other documentation related to existing products or NPI at the site.
- Provide exceptional technical support during NPI and ensure the successful manufacture of validation batches.
- Train the Manufacturing team to support manufacturing and process activities flawlessly.
- Demonstrate expertise in technical writing skills for reports, protocols, investigations, and change requests.
- Assist with day-to-day production tasks, including identifying problem causes, making process changes, and implementing new production technologies.
- Provide technical expertise for quality compliance activities such as documentation updates to batch records, SOPs, risk assessments, change control, investigations, and CAPA.
- Analyze and adjust process parameters, critical quality attributes (CQAs), and equipment performance using statistical tools during Continuous Process Verification (CPV) and Annual Product Review (APR).
- Participate in critical technical projects related to the production of commercial sterile pharmaceuticals.
- Attend project meetings to discuss customer production processes, approve production operation instructions, and resolve anomalies related to production standards.
- Promote and demonstrate EHS safe practices, ensuring all activities are conducted as per EHS standards and site safety SOPs. Participate in safety activities, HAZOPS, and process safety activities.
Education:
- Minimum requirement is a bachelor's degree in engineering, biological/chemical sciences, or related fields, or equivalent experience.
Experience:
- 2 to 4 years of pharmaceutical experience is preferred.
Knowledge, Skills, Abilities:
- Strong understanding of pharmaceutical manufacturing processes.
- Knowledge of GMP and Statistical Process Controls and related tools.
- Good computer skills and familiarity with laws and regulations relating to safety and environmental conservation.
- Flexibility, positive relationship skills, openness, and attentiveness.
- Specific experience in the production of sterile injectable drugs and packaging/visual inspection activities is preferred.
- Highly motivated to work in the pharmaceutical industry and able to work collaboratively as a team.
