We are lookin for a Regulatory Compliance & Documentation Junior Executive for one of our clients :
Well versed with all QA/QC operational standards and procedures and regulatory compliance for the product labels country wise.
Very good knowledge in international regulatory requirements for US FDA, EU, ASIAN, MIDDLE EAST countries.
Knowledge and understanding of regulatory compliance procedures of personal care products.
Being able to prepare various certificates such as COA (Certificate of Analysis), MSDS, QQF, Certificate of No Animal Testing, Certificate of GMP, Certificate of Impurities, Free Sales Certificates as per Customer’s requirement.
Knowledge on customer complaint handling
Well versed in checking the label, text and artworks as per
Studying Legal Documents and collating information in a variety of
formats.
Ensuring compliance with regulations set by the Cosmetics & Perfumes
Regulatory Agency as per country wise requirements.
Keeping up to date with changes in regulatory legislation and guidelines
Outlining requirements for labelling, storage and packaging.
Maintain product drawing/Artworks/ documents distribution record.
Maintain the MSDS, QQF which are required for the customer’s country
wise.
Responsibilities include record keeping, all documents such as
specification procedures, inspection schedule and records to QC/QA procedures.
Preparation of Specification for In-Process, Intermediate, Raw material
(RM), Packaging material (PM) testing as per regulatory requirement.
Preparation of Test Data Sheet for Intermediate, Raw material, Packaging
material & Stability Testing.
To review and prepare Impact Assessment / Risk Assessment report.
Maintain and support procedures to ensure the compliance of all cosmetic products and packaging.
Gather and maintain data for raw materials and production batches
ensuring GMP and customer compliance.
Prepare accurate, complete documentation in a timely manner as
necessary.
Preparation of product specifications.
Receiving and getting approval of the final art works for their color text,
legal requirements as per the customers’ / Country wise regulatory requirement.
Updating the legal requirements and checking the art works as per the legal requirements for the various countries / customers.
Preparation of the various certificates like COA, certificate of no animal
testing, certificate of GMP, certificate of impurities, free sale certificate as per the customer’s requirement.
To constantly engage researching new regulation updates and should be
able to take pro-active action with respect to the updating of the formulation, artwork and labelling for non-compliant products. Skills & Competencies Required:
Must have a thorough knowledge of the regulatory documentation
requirements for the personal care industry.
Should be well versed with US FDA, EU regulatory requirements.
Should be well versed in the preparation of MSDS, COA, PIF and CPNP
files.
User knowledge in JD Edwards / MS windows
English proficiency (written and verbal)
Problem Solving
Result Orientation
Environmental monitoring
Knowledge of Calibration of Instruments
Documentation and reporting
Knowledge of Cosmetic RM/ PM stability Tests
Analytical and attention to details.
Min Experience:
4 Years
Salary :
AED 5000
Temp/Perm::
Permanent
Location :
Sharjah
Posted Date:
August 3, 2022
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