Astt Manager ISO Compliance-delhi-jmpl

5 - 10 Years
Delhi

Job Description

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)

Required Candidate profile

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)

Perks and Benefits 

As Per Company Norms

Salary: Not Disclosed by Recruiter

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

Please refer to the Job description above

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