Supplier Quality Officer

Job Tittle: Supplier Quality Officer

Key Responsibilities:

 Approved auditor from any External agency / completed course as Lead Auditor.

 Audit /Visit suppliers for their Quality Compliance as per Kenvue Guidelines and applicable regulatory

guidelines.

 Drive regulatory compliance of suppliers as per current regulatory guidelines (CDSCO, Local FDA, Sch M

etc)

 Track the audit status for its compliance as per agreed supplier Audit Management SOPs and drive

effective closure of agreed action plan.

 Review of Audit evidence submitted by suppliers and ensure effective closure of observations as per

agreed Audit Action Plan (AAP) on time.

 Drive and monitor information for Global Change Control related to suppliers.

 Coordinate on the quality system related matters with Suppliers to ensure its closure.

 Collating and leading data for preparation of Supplier related Risk Assessments and its closure.

 Drive and complete mitigation plans, actions plan documented in various actions like Exit strategy,

Escalations etc related to suppliers.

Experience & Skills:

 Minimum 5 years of experience in Quality Department wrt auditing suppliers / External manufacturer

etc in Consumer or pharmaceutical industry.

 Should have knowledge of Food, drugs & Cosmetics regulatory guidelines, ICH, 21CFR210 & 211,

FSSAI, BRC, CDSCO guidelines.

 Knowledgeable wrt current IT for making effective letters, presentations, videos etc.

 Good communication & CAPA driving skills to ensure Right `Quality Management System’.

 Knowledge of Change Management, Internal Audits, Deviation management, Risk Assessment &

cGMP.

 Working experience on electronic document management systems like Viva, EtQ NxG, Trackwise,

Symphony etc is added advantage.

 Working experience in Quality Assurance or Quality Control of API or Formulation or Chemical or

Packaging Material Manufacturing facilities.

General Skills:

 Candidate must have language proficiency in Spoken/written English and 2-3 local languages.

 With Positive Mindset, Committed and responsible.

 Proactive and solution-oriented approach to challenges.

 Quality mind-set with strong analytical skills.

 Sensitivity to cultural issues and ability to work in a diverse multi-cultural environment.

 Aware about Data Integrity.

Qualification:

 B. Pharmacy / M. Pharmacy/Chemical engineering/Packaging or molding expertise

• Certified Lead Auditor wrt auditing suppliers / External manufacturer etc in Consumer or pharmaceutical industry.

• Minimum 5 years of experience in Quality Department

• Should have knowledge of Food, drugs & Cosmetics regulatory guidelines

 Working experience in Quality Assurance or Quality Control of API or Formulation or Chemical or Packaging Material Manufacturing facilities

• Knowledgeable wrt current IT for making effective letters, presentations, videos etc.

• Candidate must have language proficiency in Spoken/written English and 2-3 local languages.

• Proactive and solution-oriented approach to challenges