Sr. Manager QC- Analytical Method Development @ Sarthee Consultancy

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Sr. Manager QC- Analytical Method Development

Sarthee Consultancy
15 to > 25 Yrs
Ahmedabad
4 years ago
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Job Description

Hands on experience of QC fo Formulation dosage form.
Well experienced of facing different Regulatory Audits like USFDA, EU etc.
To handle a team of 15 to 20 analyst.
Knowledge & experience of GLP, GDP.
To have well awareness and understanding about the regulatory requirement/guidance of USFDA,EU etc.
Having experience for performance of various test like APSD by ACI & NGI, DDU, Drug content, Related compounds, etc.
Having knowledge of all sophisticated instruments like HPLC, GC, GCMS, LCMS, Karl Fischer Titrator, ACI, NGI, ADSA, etc.
Experienced of handling OOS, OOAL investigation reports.
To have knowledge of Extractable and Leachable studies of dosage form.
To guide & support all scientists for routine CMC activities like Exhibit batch release, Stability Sample analysis, Validation/Verification, Method Transfer of drug product and drug substance.
Analytical data review for all CMC activities.
Review/ finalization of Method of analysis, specifications, SOPs, change control, COAs, Stability protocols.
To handle Troubleshooting for day-to-day analysis.
Minimum 15 Years of total experience and at least 5 years of group leading.
Should be a motivation leader.

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Quality (QA-QC)
Functional Area: Not Applicable
Role/Responsibilies: Sr. Manager QC- Analytical Method Development

Contact Details:

Company: Sarthee Consultancy
Location(s): Ahmedabad

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Keyskills: method transfer control quality qc analytical method development stability studies verification validation

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Current / Recent Company (*)

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Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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Sr. Manager QC- Analytical Method Development @ Sarthee Consultancy

Home > Quality (QA-QC)