🔶 ZCL Chemical LTD Ankleshwar jobs for M.Sc M.Pharma Ph.D Analytical Chemistry apply now
🔶ZCL Chemical LTD
Executive / Senior Executive - Developmental Quality Assurance (DQA)
Job Highlights
Experience - :4 - 9 Years
Vacancy - :1 Vacancy
Location - :Ankleshwar
Not disclosed
developmental activities in Synthesis, Quality Assurance, Implementation of Developmental aM.ctivities in Analytical
Job Description
Roles and Responsibilities
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To ensure implementation of appropriate quality systems for developmental activities in Synthesis and analytical dept.
To review development documents for Regulatory submissions, including analytical method development/validation protocols and reports, product development reports, stability protocols and reports
Thorough understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents; familiarity with GLP and GCP regulations
To prepare and review SOP as per GLP requirement for analytical & synthesis dept.
To provide guidance, oversight, and direction to external partners to ensure development activities are performed in a manner compliant with regulatory expectations.
Experience to review and control analytical related documents
To bridge between QA and R&D in terms of compliance as per regulatory requirements
Vendor assessment report preparation and tentative vendor qualification report review and approval for new KSM’s.
To ensure the compliance of technology transfer relevant activities
Proposed specifications review and approval.
Analytical method development data review and approval.
Specification and Standard test procedures.
Cleaning test procedures.
Should have knowledge on Change controls, Out of trend (OOT), Out of specification (OOS), Incident, Deviation and regulatory deficiencies.
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Desired Candidate Profile
Position: Executive / Senior Executive -DQA
Location: Ankleshwar, Gujarat
DQA experience is at least 5 yrs in R&D or ARD or QA.
Only DQA experience: 5+ yrs
Department: Developmental QA
Qualification: M.Pharm / M. Sc. / Ph.D. in organic / Analytical chemistry
Salary: As per Market standards
NP: 15 to 30 days
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Industry Type
Pharma, Biotech, Clinical Research
Functional AreaEngineering Design, R&D
RoleQuality Assurance & Quality Control-Executive
Employment TypeFull Time, Permanent
Education
MS/M.Sc(Science) in Chemistry, Chemical by Engineering & Materials Science, Biotechnology, Bio-Chemistry, Organic Chemistry, Microbiology, M.Pharma in Any Specialization
Apply here
Reference - Industrial Guide [Naitik Patel]
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