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
Job Posted by ApplicantPro
Job Tags
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