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29/03 P G Ganesh
Sole Proprietorship at Perfect Placer

Views:1207 Applications:148 Rec. Actions:Recruiter Actions:0

Technical Manager/Senior Manager - Quality Systems (8-12 yrs)

Bangalore Job Code: 18355

Technical Manager/Sr Manager - Quality Systems :

- The Technical Manager/Sr Manager of Quality Systems is responsible for ensuring Co's Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Training and Laboratory Investigations, are consistently administered and followed.

- This role will lead governance meetings, Material Review Board, CAPA Review Board and continuous improvement initiatives for Quality Systems.

Responsibilities :

- Participate in inspection readiness, regulatory inspection support and self- inspection activities. Lead internal audit activities.

- Develop and refine quality system metrics.

- Provide training, qualification activities and guidance for Co's quality systems.

- Provide metrics and trending to various quality meetings.

- Works cross functionally with management within and outside Technical Operations to train and ensure consistency of use of the quality systems.

- Participate in quality system improvement and process mapping initiatives.

- Author and own site Quality Technical Agreements.

Qualification And Experience :

1. Bsc with 6+ years experience in pharmaceutical or related industry.

2. Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.

3. Ability to speak and present data and defend approaches in front of audiences.

4. Ability to comprehend technical information related to analytical methods, processes and regulatory expectations.

5. Familiarity with FDA, European and international regulatory requirements.

Remuneration :

An outstanding remuneration package that rewards professionalism and diligence will be on offer for the successful applicant as well as a well defined career path. An excellent package will be on offer for the right candidate, including an above industry base salary for the right person as well as the most complete employee benefit scheme. Don't miss out on this opportunity to join the market leader

Contact Person Name, Address & Nos. :

P.G.Ganesh
Perfect Placer

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