Quality Assurance Documentation - API @ Elemental Consultancy

Job Description

Responsibility

  Should be highly organized in work.

  Responsible to prepare and review document .

  Responsible to prepare specification / SOP / URS /CoA as per regulatory guidelines.

  Responsible to writing, editing, formatting and revising the document with clear change history.

  A clear understanding of different type of analytical techniques.

  Responsible for error free documentation & securing vital information.

  Responsible for transferring document to multiple department with secure manner.

  Responsible for coordination with CFT to understand the process, trend and purge data to frame the specification.

  Keep monitoring document revision periodically.

  Monitoring all requirement before transferring document to AVL / CRPL.

  Handling all corresponds, archival & retrieval of document on time.

  Follow environment , health & safety requirements all the time in the workplace ensuring individual & lab safety.

Technical Skill

  Should have exposure API analytical documentation environment.

  Must have sound knowledge of 21 CFR compliance.

  Muxt have sound knowledge of ALCOA +.

  A clear communication & written skill, command in English.

  Very good in analytical thinking and have approach towards solving problem.

 Qualification:

  M Sc (Organic / Analytical Chemistry) with 5+ years of relevant experience.

 Please note MSC Microbiology and MPharm also accepted . 

ANDA Regulatory understanding would be an added advantage. Looking from QA Analytical and not Process.

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   documentation qa analytical api