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Chieron Active Ingredients
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DQA - Executive or Sr. Executive

DQA - Executive or Sr. Executive

Chieron Active Ingredients

0 - 5 years

1 - 5 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

usfda regulatory filing ema glp gmp capa rca change control qbd fmea qos ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title: Sr. Executive/Executive

Job Summary, Duties/Responsibilities:

Ensure proper guidance on quality issues to the Product Development Teams

Review the documents received from R&D, AR&D, etc. so that the same can be shared with authorities and customers

. coordination communication and to respond customer complaint/query and regulatory authority.

Review the process change proposals and help the team members provide guidance on change proposals
Review the in-house expert reports/Quality overall summary (QOS) prepared by the team members
Ensure proper stage gate compliance at various stages of product development
Ensure that internal audits are conducted properly
Review the developmental reports and other documents
Ensure appropriate qualification of API.
Ensure appropriate qualification of external manufacturing sites
Ensure self-inspection programs are conducted properly across R &D.
Review the existing GMPs, STPs, GLPs or SOPs and update them if required
Help the team members manage change controls, deviations, incidents
Ensure international customers audits, regulatory audits, etc. is handled in a suitable manner
Ensure proper maintenance of central documentation, i.e. the Development Quality Assurance (DQA) document cell
Support audits/ quality investigations issues of other Business units
Ensure thorough Inspection of quality till the exhibit batch stage
Ensure quality by design, i.e. ensure robustness of product and process

Required Skills/Abilities:

Working experience in QbD and other new ICH, FDA guidelines

Education and Experience:

Required Education: M.Sc or equivalent.

Minimum Experience:

5-8years experience as DQA in research environment

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