Manager - 2

SUN PHARMA


Date: 9 hours ago
City: Vadodara, Gujarat
Contract type: Full time
Job Title

CMC-IRA

Job Grade

G11B/G11A

Function

India Regulatory Affairs

Location:

Baroda

Job Summary

Review of CMC documents. Documents include but not limited to following:

Drug Substance

  • Structural formula, molecular formula and relative molecular weight
  • General description of raw materials
  • Identification of critical steps in process and control
  • Flow diagram of manufacturing process
  • Description and characterization of drug substance
  • Physiochemical data: (Chemical name and structure, Empirical formula, Molecular weight)
  • Physical properties:- Description, Solubility, Rotation, Partition coefficient, Dissociation constant.
  • Analytical Data: Elemental analysis, Mass spectrum, NMR spectra, IR spectra, UV spectra, Polymorphic identification
  • Complete monograph specification and STP
  • Impurities (name, manufacturer)
  • Residual solvent/ other volatile impurities (OVI) estimation
  • Manufacturing process for drug substance
  • Validation of manufacturing process [assay method, impurity estimation method, residual solvent/other volatile impurities(OVI) estimation method]
  • Manufacturer(s)
  • Stability of drug substance
  • Tests and evaluation of packaging materials
  • Specifications of primary and secondary packing
  • Container closure system
  • Reference standards
  • Justification of specifications
  • Storage and shipping conditions of drug substance
  • Protocol of stability study, results and conclusions
  • Manufacturing process development
  • Selection and justification of critical steps
  • Filling procedure for the active ingredient, in-process controls
  • Stabilization of active ingredient

Drug Product

  • Justification of final qualitative/quantitative formula
  • Manufacture of drug product
  • Description and composition of drug product
  • Description of manufacturing process
  • Protocol of stability study, results and conclusions
  • Stability of drug product
  • Tests and evaluation of packaging materials
  • Specifications of primary and secondary packing
  • Container closure system
  • Finished product specification and STP
  • Justification of specifications
  • Excipient compatibility study
  • Dissolution Study
  • In process quality control check and report
  • Certificate of analysis
  • Validation of analytical procedures
  • Forced degradation study
  • Process validation protocol and Report
  • Labeling
  • Details of equipment and facilities for production of drug product: master formula, batch record and set release documentation in respect of consistency batches
  • Description of batch identification system
  • Control of excipients (adjuvant, preservative, stabilizers and others)
  • Use of new adjuvants, preservatives, stabilizers and excipients

Areas Of Responsibility

  • Checking of CMC documents.
  • Discussion with CFT for corrections
  • Co-ordination for finalized CMC documents from stakeholders
  • Review and approval of CCR
  • Compilation of CMC dossier for regulatory submission including query responses

Travel Estimate

Only if required

Job Scope

Internal Interactions (within the organization)

Yes

External Interactions (outside the organization)

Yes, in case of CMO projects

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

 Educational Qualification

M. Pharma

Specific Certification

Experience

5-10 years

Skill (Functional & Behavioural): Knowledge of CMC requirements/understanding of ICH quality guidelines

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Customer Support Manager

IDX, Vadodara, Gujarat
4 days ago
Who We Are:Investis Digital is a global digital communications company. We combine effective storytelling with innovative digital approaches to help businesses communicate clearly and authentically with any audience. Using performance marketing and corporate communications, we craft a seamless presence for our clients, positively influencing the awareness, affinity, and action of the people that matter most. Founded in 2000, we have...

Software Tester QA

Ethics Infotech, Vadodara, Gujarat
1 week ago
Role & Responsibilities Reviewing software requirements and preparing test scenarios. Executing tests on software usability. Analyzing test results on database impacts, errors or bugs, and usability. Preparing reports on all aspects related to the software testing carried out and reporting to the design team. Interacting with clients to understand product requirements. Participating in design reviews and providing input on requirements,...

Executive Design

Reliance Industries Limited, Vadodara, Gujarat
1 week ago
Take-up conceptualization, development, and execution of innovative and efficient designs for composite products.Creating design strategies, conducting feasibility studies, utilizing CAD software, optimizing material selection, and staying updated on industry trends and emerging technologies to drive continuous improvement.Ensure to meet the organization goals related to Pultrusion, Filament Winding, Mass Transport, Hand lamination, Centrifugal casting, SMC, etc.Ability to conceive new ideas to...