Profile HR Consultants Pvt Ltd. logo

Site Head Quality Control ( Peptides)

15 years

0 Lacs

greater hyderabad area

Posted:1 day ago| Platform: Linkedin logo

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Skills Required

api development qc audit lims data migration planning testing stability audits compliance reports drive management monitoring analysis evaluation compensation

Work Mode

On-site

Job Type

Full Time

Job Description

CLIENT: Integrated CRO with API Process Development for NCEs and Peptides,present in over 80 countries.


KEY DELIVERABLES:


  • Head Site QC and manage investigations of product issues, laboratory incidents (LIR), OOS, OOT & OOC.

  • Lead & oversee the review of audit trails (CDS & Non-CDS) to ensure cGMP & regulatory compliance.

  • Supervise LIMS activities, including data review, migration, & error resolution.

  • Direct planning & execution of batch releases for raw materials, intermediates, & finished products using LIMS & SAP.

  • Plan & execute finished products, intermediate testing, and stability studies.

  • Conduct & oversee internal audits, review compliance reports, & drive resolution.

  • Review, prepare, & ensure adherence to SOPs; monitor & guide the analytical team.

  • Manage change control processes, SOP revisions, Audit based revision & new SOP initiation.


Incumbent profile:


  • M.Sc (Chemistry) with 15 years experience in Quality Control - Peptides.

  • Strong exposer in Stability section, ie, Stability sample management,monitoring of analysis, validation batch evaluation and co-ordinate with regulatory requirements

  • 21 CFR Compliance activity in laboratory.


Annual Compensation: 20-25LPA


Queries:

Anoop Sinha-CEO, PROFILE HR CONSULTANTS PVT LTD

<career@profileconsultantsindia.com>

Cell- 9773520069

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