Assistant Mgr / Deputy Mgr - Corporate Quality - Intelligence Team

Zydus Lifesciences Ltd, Ahmedabad

10 - 15 years

10 - 17 Lacs

Ahmedabad

Posted:1 week ago| Platform:

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Skills Required

GMP Quality Assurance Quality policy Corporate Quality Assurance Capa CQA usfda Intelligence Compliance QMS

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities:

To enhance the quality system by imparting cGMP knowledge and updating regulatory requirements to the sites.
To provide new regulatory guidance and technical documents to the site.
To maintain a quality intelligence database and inform the concerned site about current regulatory requirements, updates and changes as and when required.
To prepare corporate quality policy, standard practices, and corporate directives for system harmonization across all sites.
To evaluate and ensure continual improvement of the quality management system.
To verify policy implementation at the site and extend the identified gaps to the site for compliance.
To review and evaluate regulatory guidelines, other company 483s, warning letters and inspection reports as per current regulatory requirements and extend identified gaps into quality intelligence portal to sites for compliance.
To inform the Zydus family about new quality issues, current regulatory inspection trends, forecasts and best possible practices.
To impart policy training to the site as and when required.
To initiate corporate change controls for preparation and revision of quality policies.
To review, verify and monitor the implementation of extended Global CAPA, Policy implementation observations and quality intelligence observations at sites.
To perform any other activity assigned by HOD, as and when required.

Preferred candidate profile:

2 Vacancies: one is for QA OSD background and second is for QA Injectable background.

Candidate must be from pharma QA (OSD or Injectable) background.
Must have Good communication skill, drafting skill and interpersonal skills.
Must ready to travel to site location for inspections and audit.
Must be ready to work at Ahmedabad location.

More Jobs at Zydus Lifesciences Ltd, Ahmedabad

Assistant Mgr / Deputy Mgr - Corporate Quality - Intelligence Team

Ahmedabad

10.0 - 15.0 yrs

INR 10 - 17 Lacs

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