Job Description

Job Description

Job Description

Summary and Objective

• Assessed each ingredient in the formula for compliance to various regulations both local, federal and other countries like EU. (e.g. Prop 65, EU 1223/2009, New York regulations, Canadian regs. China, Australia, Brazil, India, NZ, UK among others)
• Evaluate ingredients for VOC/CARB regulations as per category of Product
• Create Qualitative/Quantitative Formula
• Create Ingredient Listings
• Create SDS
• Create the Regulatory Document dossier/package
• Coordinate submission of FG specification and Stability Studies
• Evaluate all the components of the product for the following features/claims and issue Declaration Certificate:

• Vegan Statement
• Non-Animal Testing Statement
• Compliance to EU regulations 1223/2009
• Gluten-Free statement
• CMR 1a, 1b & 2 as per Article 15 of EU directive 1223/2009 & Annex VI
• PAO Statement

• Issue Shelf-Life statement
• Evaluate proposed Alternate Raw Materials for equivalency and prepare and submit ERMA requirements for BBW and VSB
• Evaluate proposed Alternate Raw Materials for equivalency and submit proposal to Edgewell/Cremo, Henkel, Medline for approval.

Addressed below requirements specific to some customers:

• Review each component of the formula for compliance to the Leaping Bunny and sign the Leaping Bunny certificate

• Provide statements and level and/or presence of rare ingredients as per requirements for registration of the product to various countries by the customer.

• Investigate customer's complaint of non-compliance, e.g. discrepancy between results of stability study and specification issued to the customer.

• Oversee validity of waiver and deviation reports

• Investigate issues raised by the customer on how the choice of ingredients in the formula will justify their claims, e.g. RSPO, clean chemistry.

Quality:

• Support Quality by determining appropriate GMP to implement to BIL system.
• Define tests required by different government entities like, FDA, USP monograph, BP methodology etc.
• Determine the importing requirements/complaint of other countries
• Analyse each component of the formula for compliance to issue Safety Assessment certificate for customers like Revlon
• Evaluate formula for compliance to local and foreign regulations, like for example restricted and prohibited colorants and bleach ingredients.
• Assessed BIL SDS's for accuracy and compliance for BIL products as well as for SDS's submitted by customers.
• Review and sign clearance documents for suppliers before they approve PO's for hazardous material.
• Review and sign documents for hazardous waste disposal by third party
• Define procedure for allergenic/sensetizer testing of bleach products
• Review product for registration in Australia
• Review product for REACH registration in EU

Registration of Facility:

• Drug Manufacturing License
• FDA Establishment Registration
• MoCRA registration
• RSPO Registration

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