Incharge Corporate Quality Assurance-delhi-jmpl

10 - 15 Years
Delhi

Job Description

Purpose of the Position (Incharge- CQA): The Profile requires the person to handle CQA activities and to ensure that all CQA guidelines are prepared based on current GMP and ISO guidelines.

1. Responsible for preparation, review and approval of guidelines to prepare QMS documents as per ISO and GMP guidelines.
2. Responsible to conduct trainings on QMS guidelines as per ISO and GMP requirements.
3. To give regular update to all employees on changes in ISO and GMP guidelines.
4. To conduct regular CQA audit of all departments.
5. To perform liaison activities with State FDA & CDSCO.
6. To conduct vendor evaluation activities for RM and PM.
7. Any other task assigned by Reporting Manager.
8. To review artwork related work in coordination with QC and QA deptt.

Qualification- B.Sc.( Biotech)/ M.Sc. ( Biotech)/B.Tech (Biotech)
Experience- 10 to 15 years in manufacturing, diagnostic, vaccine
Key skills: working experience in Pharmaceutical, Medical devices or Diagnostic kits manufacturing industries in QA/CQA department.
Experience: 10-15 years in any healthcare industry in manufacturing, diagnostic, vaccine industry.
Technical Skills: Knowledge of ISO standards/Medical Device Rules 2017

Working Skills:

1. Knowledge of MS Office
2. Knowledge of SOPs
3. Strong analytic /problem solving/ decision making skills
4. Able to work under pressure in a fast-paced environment
5. Strong interpersonal, leadership, influencing and negotiation skills
6. Resilient and determined; focused on results



Salary: INR As Per Company Norms

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Executive

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Purpose of the Position (Incharge- CQA): The Profile requires the person to handle CQA activities and to ensure that all CQA guidelines are prepared based on current GMP and ISO guidelines.

1. Responsible for preparation, review and approval of guidelines to prepare QMS documents as per ISO and GMP guidelines.
2. Responsible to conduct trainings on QMS guidelines as per ISO and GMP requirements.
3. To give regular update to all employees on changes in ISO and GMP guidelines.
4. To conduct regular CQA audit of all departments.
5. To perform liaison activities with State FDA & CDSCO.
6. To conduct vendor evaluation activities for RM and PM.
7. Any other task assigned by Reporting Manager.
8. To review artwork related work in coordination with QC and QA deptt.

Qualification- B.Sc.( Biotech)/ M.Sc. ( Biotech)/B.Tech (Biotech)
Experience- 10 to 15 years
Key skills: working experience in Pharmaceutical, Medical devices or Diagnostic kits manufacturing industries in QA/CQA department.
Experience: 10-15 years in any healthcare industry in manufacturing, diagnostic, vaccine industry.
Technical Skills: Knowledge of ISO standards/Medical Device Rules 2017

Working Skills:

1. Knowledge of MS Office
2. Knowledge of SOPs
3. Strong analytic /problem solving/ decision making skills
4. Able to work under pressure in a fast-paced environment
5. Strong interpersonal, leadership, influencing and negotiation skills
6. Resilient and determined; focused on results

Education-

UG:B.Sc - Bio-Chemistry, B.Tech/B.E. - Bio-Chemistry/Bio-Technology

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:Talent Acquisition

Contact Company:J.Mitra and Co. Pvt. Ltd

Email :talentacquisition@jmitra.co.in

Website:http://www.jmitra.co.in