Jan Lapid

Responsible for overseeing Compounding Department, executing manufacture of product batches ranging from 5 kg to 2500 kg in size.

Product catalogue includes topical ointment and cream product bases, oral rinse products, topical lozenge and gum base products.

Responsible for compounding production batch record review. Review encompasses:

• Finished batch record release for product filling
• Review of current batch manufacturing processes and batch record edits for process improvements
• Creation of new product batch records for new product onboarding

Responsible for execution of development batches for new product onboarding

• creating manufacturing processes for batch scale up from lab bench to full scale production.

Successfully created manufacturing processes for scale up batch sizes

• Responsible for oversight of Drug and Chemical Dispensing operations alongside Bulk Manufacturing operations.
• Ensure raw materials are received, stored, and dispensed according to applicable material specifications, procedures, and batch record instructions.
• Responsible for tracking raw material inventory in electronic inventory system.
• Work alongside supply chain management to ensure sufficient inventory of raw materials for manufacturing operations.
• Ensure new incoming raw materials are sampled and tested according to specification.
• Work alongside chemical testing lab to ensure approval of raw materials in timely manner.
• Create, review, update, and approve standard operating procedures.
• Review, update, and approve manufacturing batch records.

• Responsible for oversight of Bulk Manufacturing Operations of sterile injectables.
• Provide real-time decisions for manufacturing operations.
• Review and approve manufacturing batch records for lot release.
• Review, edit, and approve manufacturing batch records.
• Write, review, approve manufacturing deviations/investigations.
• Work directly with pharmaceutical technology engineers and lab to create manufacturing processes for new products.

• Perform aseptic manufacturing and packaging operations line clearances.
• Observe aseptic manufacturing processes.
• Work alongside manufacturing operations management to provide immediate aseptic operations decisions based on approved standard operating procedure.
• Perform in-process AQL inspections.
• Review and approve manufacturing batch records for product release.