Job Description
Purpose of Post : Responsible to support Management of Chemical suppliers supporting to India Business through their assessments. Audit and suppliers visit for their Quality Compliance as per J&J Guidelines and applicable regulatory compliance. Track the audit status for its compliance as per agreed supplier Audit Management SOP, communicate with suppliers for Audit responses and their compliance. Review of Audit evidences submitted by suppliers and ensure effective closure of observations as per agreed Audit Action Plan (AAP) on time.
Purpose of Post : Responsible to support Management of Chemical suppliers supporting to India Business through their assessments. Audit and suppliers visit for their Quality Compliance as per J&J Guidelines and applicable regulatory compliance. Track the audit status for its compliance as per agreed supplier Audit Management SOP, communicate with suppliers for Audit responses and their compliance. Review of Audit evidences submitted by suppliers and ensure effective closure of observations as per agreed Audit Action Plan (AAP) on time.
Key Responsibilities:
• Management of Chemical suppliers supporting to India Business through their assessments.
• Audit /Visit suppliers for their Quality Compliance as per J&J Guidelines and applicable regulatory compliances.
• Track the audit status for its compliance as per agreed supplier Audit Management SOP, communicate with suppliers for Audit responses and their compliance.
• Review of Audit evidences submitted by suppliers and ensure effective closure of observations as per agreed Audit Action Plan (AAP) on time.
• Management of Change controls related to chemical suppliers supporting to India Business.
• Coordinate on the quality system related matters with Suppliers to ensure its closure.
• Collating and capturing basic data for Monthly report of India.
• Management of progress of CAI / EAI Chemical suppliers as per J&J guidelines.
• Drive and complete mitigation plans, actions plan documented in various actions like Exit strategy, Risk assessment forms, Escalations etc related to Chemical Suppliers.
• Monthly review with key suppliers on their progress on Quality parameters.
• Management of Chemical suppliers supporting to India Business through their assessments.
• Audit /Visit suppliers for their Quality Compliance as per J&J Guidelines and applicable regulatory compliances.
• Track the audit status for its compliance as per agreed supplier Audit Management SOP, communicate with suppliers for Audit responses and their compliance.
• Review of Audit evidences submitted by suppliers and ensure effective closure of observations as per agreed Audit Action Plan (AAP) on time.
• Management of Change controls related to chemical suppliers supporting to India Business.
• Coordinate on the quality system related matters with Suppliers to ensure its closure.
• Collating and capturing basic data for Monthly report of India.
• Management of progress of CAI / EAI Chemical suppliers as per J&J guidelines.
• Drive and complete mitigation plans, actions plan documented in various actions like Exit strategy, Risk assessment forms, Escalations etc related to Chemical Suppliers.
• Monthly review with key suppliers on their progress on Quality parameters.
Candidate Profile :
• Minimum 2 years of experience in Consumer or pharmaceutical industry.
• Should have knowledge of Drug & Cosmetics regulatory guidelines (ISO/Drugs & Cosmetics Act/ICH guidelines).
• Knowledge of Change Management, Internal Audits, Deviation management, Risk Assessment & cGMP.
• Knowledge of computer systems, Working on MS Word, Excel & PowerPoint. Working experience on Electronic document management systems like Trackwise, Symphony etc is added advantage.
• Working experience in Quality Assurance or Quality Control of Chemical or Packaging Material Manufacturing facilities.
• 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 and strong analytical skills.
• Sensitivity to cultural issues and ability to work in a diverse multi-cultural environment.
• Minimum 2 years of experience in Consumer or pharmaceutical industry.
• Should have knowledge of Drug & Cosmetics regulatory guidelines (ISO/Drugs & Cosmetics Act/ICH guidelines).
• Knowledge of Change Management, Internal Audits, Deviation management, Risk Assessment & cGMP.
• Knowledge of computer systems, Working on MS Word, Excel & PowerPoint. Working experience on Electronic document management systems like Trackwise, Symphony etc is added advantage.
• Working experience in Quality Assurance or Quality Control of Chemical or Packaging Material Manufacturing facilities.
• 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 and strong analytical skills.
• Sensitivity to cultural issues and ability to work in a diverse multi-cultural environment.
Additional Information
Experience : 2 years
Qualification : B.Pharm, M.Pharm
Location : Mulund, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 10th March, 2019
Experience : 2 years
Qualification : B.Pharm, M.Pharm
Location : Mulund, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 10th March, 2019
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