Job Title:CMC-IRAJob GradeG11B/G11AFunction:India Regulatory AffairsLocation:BarodaJob SummaryReview 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)
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 EstimateOnly if requiredJob ScopeInternal Interactions (within the organization)YesExternal Interactions (outside the organization)Yes, in case of CMO projectsGeographical ScopeFinancial Accountability (cost/revenue with exclusive authority)Job RequirementsEducational QualificationM. PharmaSpecific CertificationExperience5-10 yearsSkill (Functional & Behavioural): Knowledge of CMC requirements/understanding of ICH quality guidelines
