Ensure audit preparedness by preparing the relevant document.
Support verification/validation activities and ensure regulatory compliance based on the outcome of the risk assessment.
Scheduling, planning, managing and executing process validation studies and authoring related plans, summary reports and protocols.
Authoring relevant standard operating procedures for ensuring compliance with the companys policies
Preparation of bulk manufacturing process & Product filling and packaging process verification/validation plan, protocol, and report
Develop reports and analyses to expose potential risks and gaps that need corrective action or preventative action
Assess the impact of regulatory changes on the company: monitor & perform gap analysis
Assist in the implementation of optimal regulatory strategies to ensure regulatory and commercial success in the most effective manner.
Ensure timely and appropriate reactions to regulatory changes.
Requirements:
Bachelor of Science, preferably in Chemistry, Biochemistry, Pharmacy, Biomedical Science or similar
Minimum 1 year of experience within the regulatory environment and in the Medical Device, Pharmaceutical, Cosmetic, Health Food, Dietary Supplement or other FMCG industry
Strong communication and engagement skills, with an ability to deal with potentially contentious issues effectively
Interested candidates who wish to apply for the advertised position to send in your resume.
EA License No.: 13C6305
Registration No.: R1982411
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