ADL Manager- Otsuka Pharma, Ahmedabad

Otsuka Pharmaceutical India Pvt Ltd

7 - 12 years

5 - 12 Lacs

ahmedabad

Posted:None| Platform:

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Skills Required

hplc analysis spectroscopy analytical method development research and development

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Timely develop and validate new analytical methods for formulations in line with the marketing requirements.
Resolve issues related to analytical methods of existing products as and where they exist if any at the QC lab levels.
Analytical method development and validation shall be in line with required documentation as per cGMP / GLP requirements following the laid down Quality management procedures by CQA.
Review and approval of the analytical method validation protocol and report.
Review and approval of final method development report as a part of the technology transfer document (TTD).
Review and approve new Method of analysis (MOAs) or any changes as necessary thereafter in the existing MOAs in line with pharmacopeial or customer requirements.
Facilitate analytical method transfer of new products to QC lab by providing physical presence of ADL personnel during the transfer.
Face customer or regulatory audits and as and when required be available as auditee.
Initiate any changes or upgradation in lab or equipment set up as necessary with time.
Handle and guide team of ADL personnel for above activities.

Preferred candidate profile

Managerial skills
Problem solving and decision making skills
Guiding skills
Team development skills
System thinking
Delegation

Interested candidate can send their resume on Anee.Silas@otsukapharma.in

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