QMS Lead /Manager QMS

* Only Female Candidates outside South Region are Preferred

JOB DESCRIPTION
1. Position Description

Job title: QMS Lead/Manager QMS

Experience : 10 -15 years of overall experience in the field with 5 to 7 years of experience on people handling.

Department: Quality Assurance -Quality System In charge

Reports to : Head - Quality

Location: Madurai

Company:Amway India Enterprises Pvt Ltd

Business:Beauty & Nutrition

2. Job Purpose

Job purpose:

• To Handle Quality System and Documentation in Quality Assurance Department. To Plan, coordinate and execute all Quality System Documentation Activities.

3. Basic Qualifications

Job Requirements

Education:

• M Sc in Chemistry/Biochemistry/Microbiology or any other relevant Experiences.

Skills & Knowledge

• Having good Knowledge of Quality Systems and Documentation requirement for Food and Cosmetics
• Knowledge of FSSAI and HACCP requirements
• Knowledge of Regulatory audits
• Knowledge of Site Master File
• Knowledge of Quality Manual

Competencies

• Planning and Prioritization Skills
• Customer orientation
• Initiative & Creative
• Reliability, team work & leadership
• Excellent interpersonal relationship building skills
• Excellent communications skills
• Having work exposure in Documentation.

4. Roles and Responsibilities

Roles and Responsibility

• Responsible to set up Team to develop Quality Systems in the company.
• Responsible for leading, planning and monitoring of day-to-day activities of Quality System team.
• Preparation, review and implementation of Quality System SOPs, Quality Manual, Site Master File and related documentation.
• Coordination with Manufacturing team to preparation and implementation the Equipment and General SOPs.
• Coordination with R & D and Manufacturing team to preparation and implementation the product BMRs and BPRs.
• Review and control of SOPs, STPs, Specifications, Batch production records, Log registers and raw data sheets.
• To co-ordinate and conduct trainings.
• To provide training to team members on Quality documents.
• Preparation and archival of APQR.
• Assign numbers to quality documents like Change control, Deviation, OOS, CAPA, Quality Risk Assessment and Market complaints.
• To keep a track of CAPA, change controls, deviations, quality system documents and implementation of the same.
• To conduct Self inspections and archival of its reports.
• To assist in External audits.
• To review the executed Batch production records for product release.
• To investigate the product recalls report and implementation of CAPA.
• Overall responsible for the issue and archival of all types of Quality documents of plant.
• Responsible for compliance for internal and external audits.
• In-depth understanding of regulatory requirements, exposure to all the regulatory guidelines and first hand exposure to regulatory audits Local FDA, USFDA etc,
• Responsible for co-coordinating with customer departments like Quality Assurance, Functional departments like Warehouse, Engineering, EHS & HR departments for cross functional activities.