Astt Manager ISO Compliance-delhi-jmpl
Purpose of position : To ensure compliance as per ISO:9001 & ISO:13485 guidelines.
Job Responsibility:
1. To impart trainings on ISO 9001 & 13485 guidelines.
2. To impart trainings on Quality Policy, Quality Manual and Quality Objectives.
3. To prepare annual internal audit schedule and monthly audit plan of all departments.
4. To conduct internal audit as per approved audit schedule and plan. In case of any deviation from approved schedule and plan, information shall be provided to MR and top management.
5. To prepare internal audit report of all departments and circulate to all concerned for closure dates.
6. To verify closure of all observations and plan CAPA for all non-compliances.
7. To update management about summary of all audit findings, closure status and CAPA planned.
8. To organize and prepare Minutes of Meeting of Management Review Meeting.
9. To update all concerned departments for /revision/updates/changes related to ISO guidelines.
10. To monitor compliance and effectiveness of Medical checkup SOP.
11. To monitor compliance and effectiveness of Personnel Hygiene SOP.
12. To monitor compliance and effectiveness of Pest control SOP.
Key Skills: Preference to candidate working in medical devices Industry.
Sound knowledge of ISO 9001 & 13485, Certified Lead Auditor from any ISO Certifying Company.
Awareness about QA/QC, manufacturing and warehousing of medical Devices Industry.
Location: New Delhi
Required Experience: 05 to 10 Years
Requisite Qualification, MSC (Biotech), B Sc (Biotech)
Job Responsibility:
1. To impart trainings on ISO 9001 & 13485 guidelines.
2. To impart trainings on Quality Policy, Quality Manual and Quality Objectives.
3. To prepare annual internal audit schedule and monthly audit plan of all departments.
4. To conduct internal audit as per approved audit schedule and plan. In case of any deviation from approved schedule and plan, information shall be provided to MR and top management.
5. To prepare internal audit report of all departments and circulate to all concerned for closure dates.
6. To verify closure of all observations and plan CAPA for all non-compliances.
7. To update management about summary of all audit findings, closure status and CAPA planned.
8. To organize and prepare Minutes of Meeting of Management Review Meeting.
9. To update all concerned departments for /revision/updates/changes related to ISO guidelines.
10. To monitor compliance and effectiveness of Medical checkup SOP.
11. To monitor compliance and effectiveness of Personnel Hygiene SOP.
12. To monitor compliance and effectiveness of Pest control SOP.
Key Skills: Preference to candidate working in medical devices Industry.
Sound knowledge of ISO 9001 & 13485, Certified Lead Auditor from any ISO Certifying Company.
Awareness about QA/QC, manufacturing and warehousing of medical Devices Industry.
Location: New Delhi
Required Experience: 05 to 10 Years
Requisite Qualification, MSC (Biotech), B Sc (Biotech)
Salary: INR As Per Company Norms
Industry:Pharma / Biotech / Clinical Research
Functional Area:Legal, Regulatory, Intellectual Property
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Keyskills
Desired Candidate Profile
Job Responsibility:
1. To impart trainings on ISO 9001 & 13485 guidelines.
2. To impart trainings on Quality Policy, Quality Manual and Quality Objectives.
3. To prepare annual internal audit schedule and monthly audit plan of all departments.
4. To conduct internal audit as per approved audit schedule and plan. In case of any deviation from approved schedule and plan, information shall be provided to MR and top management.
5. To prepare internal audit report of all departments and circulate to all concerned for closure dates.
6. To verify closure of all observations and plan CAPA for all non-compliances.
7. To update management about summary of all audit findings, closure status and CAPA planned.
8. To organize and prepare Minutes of Meeting of Management Review Meeting.
9. To update all concerned departments for /revision/updates/changes related to ISO guidelines.
10. To monitor compliance and effectiveness of Medical checkup SOP.
11. To monitor compliance and effectiveness of Personnel Hygiene SOP.
12. To monitor compliance and effectiveness of Pest control SOP.
Key Skills: Preference to candidate working in medical devices Industry.
Sound knowledge of ISO 9001 & 13485, Certified Lead Auditor from any ISO Certifying Company.
Awareness about QA/QC, manufacturing and warehousing of medical Devices Industry.
Location: New Delhi
Required Experience: 05 to 10 Years
Requisite Qualification, MSC (Biotech), B Sc (Biotech)
Education-
UG:B.Sc - Chemistry
PG:MS/M.Sc(Science) - Biotechnology
Doctorate:Doctorate Not Required
Company Profile
J.Mitra and Co. Pvt. Ltd
A Leading WHO-GMP, ISO Certified Company in the field of specialised Medical Equipments, Diagnostic Kits & Reagents as well as Blood Bags.WHO-GMP, ISO Certified Company.
View Contact Details+
Recruiter Name:Talentacquisition
Contact Company:J.Mitra and Co. Pvt. Ltd
Email :talentacquisition@jmitra.co.in
Website:http://www.jmitra.co.in