Urgent Hiring For Quality Control Roles MSN Formulations Division

Job Title: Quality Control Analyst Formulation (OSD & Injectables)

Experience:

Job Posting Purpose:

Formulation QC Analyst

Key Responsibilities:

• Conduct routine and non-routine testing of

  raw materials

  ,

  in-process

  ,

  finished products

  , and

  stability samples

  using

  HPLC

  ,

  GC

  ,

  LCMS

  ,

  ICPMS

  ,

  Dissolution

  , etc.
• Perform

  method development, validation, verification

  , and

  method transfer

  in compliance with ICH and regulatory guidelines.
• Handle and maintain laboratory instruments; ensure

  equipment calibration

  ,

  qualification

  , and

  preventive maintenance

  .
• Record, analyze, and report data in compliance with

  GMP

  ,

  GLP

  ,

  LIMS

  , and

  data integrity

  requirements.
• Support

  stability studies

  ,

  impurity profiling

  , and

  E&L (Extractables & Leachables)

  assessments.
• Participate in

  OOS/OOT investigations

  ,

  root-cause analysis

  , and implementation of

  CAPAs

  .
• Collaborate with QA, R&D, and manufacturing teams for timely completion of projects.
• Assist in preparing documentation for

  regulatory submissions

  and support during

  regulatory inspections

  (e.g., USFDA, MHRA).
• Provide training and support to junior analysts as needed.

Required Skills and Qualifications:

• B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences, Chemistry, or related field.

• 2 to 8 years

  of hands-on QC experience in

  pharmaceutical formulations

  (OSD & Injectables).
• Proficient in analytical techniques:

  HPLC

  ,

  GC

  ,

  Dissolution

  ,

  LCMS

  ,

  ICPMS

  ,

  UV

  ,

  Karl Fischer

  , etc.
• Strong understanding of

  method development

  ,

  validation

  ,

  ICH guidelines

  ,

  IP/FP testing

  , and

  stability protocols

  .
• Knowledge of

  LIMS

  ,

  21 CFR Part 11

  ,

  GMP

  ,

  GLP

  , and

  data integrity

  practices.
• Experience working in regulated environments with exposure to

  USFDA

  ,

  EU

  ,

  MHRA

  , or other inspections.

Preferred Attributes:

• Good documentation and analytical skills.
• Ability to work in a fast-paced, deadline-driven environment.
• Strong team player with good communication skills.
• Exposure to

  regulatory submissions

  ,

  change controls

  , and

  SOP writing

  .

  Role & responsibilities

umamaheswari.pasam@msnlabs.com