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Executive / Sr. Executive - Quality Assurance

Pharmaffiliates Analytics Synthetics P Ltd
3 - 8 yrs
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1,00,000 - 5,00,000 P.A. Openings: 3 Posted 6 days ago Job Applicants: 588 Job Views: 1128

Job Description

 
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    • Middle level managerial responsibility of Quality Management System (QMS).
    • Should be able in Co-ordination with Research and Development department (R&D).
    • To design Quality Systems as per latest requirements and ensure compliance of the same as per the regulatory standards e.g. ICH, WHO, ISO / IEC 17025, ISO 9001.
    • To prepare & execute Validation Master Plan .
    • To conduct training on GMP, Hygiene & critical systems SOP.
    • Analytical validation protocols and execution of the same.
    • To ensure that all equipments and instruments are qualified before use.
    • To evaluate testing records for compliance and final release of test reports.
    • Responsible for handling product complaints.
    • To update Quality Manual, Training Manual & Site Master File.
    • To effectively monitor Change Controls/ Deviations / CAPA system.
    • Preparation, Issuance & review of Test Data Sheets.
    • To handle regulatory inspection & other country specific audits.
    • To ensure effective document control process & archival of GMP related documents.
    • Knowledge of Analytical Chemistry with the experience of handling instruments like GC/ HPLC/ UV etc will be preferable

Salary: INR 1,00,000 - 5,00,000 P.A.

Industry: Pharma / Biotech / Clinical Research

Functional Area: Production , Manufacturing , Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Executive

Employment Type: Permanent Job, Full Time

Keyskills

Desired Candidate Profile

    Please refer to the Job description above

Education-

UG: B.Pharma - Pharmacy, B.Tech/B.E. - Any Specialization, Chemical

PG:MS/M.Sc(Science) - Bio-Chemistry, Biotechnology, Chemistry, M.Pharma - Pharmacy

Company Profile:

Pharmaffiliates Analytics Synthetics P Ltd

Pharmaffiliates Analytics & Synthetics (P) Ltd., is an US-FDA Approved Integrated Contract Research Organisation (CRO) services provider offering its expertise in Custom Synthesis, Analytical, Quality Assurance and Regulatory services with a right blend of Competent people, state-of-the-art infrastructure facilities, cutting - edge technology and certified processes to pump your development pipeline with time & cost advantages and thus combat in the highly competitive markets and also acquiring the niche segments. We serve to be your strategic partner for outsourcing and help you right from strategic planning of CMC blue-print accelerating the filing & representation for NDAs and ANDAs submitted in any regulated and semi- regulated markets, which save your time and efforts by focusing them in your core areas of operations.
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Rachna Malik Company HR Pharmaffiliates Analytics Synthetics P Ltd

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