hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Assistant Manager QC Analytical Development & Drug Regulatory Affairs

2.00 to 7.00 Years   Delhi   02 Mar, 2021
People Alliance Workforce Private Limited
Job LocationDelhi
EducationNot Mentioned
SalaryRs 3.0 - 4.5 Lakh/Yr
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

The requirement for Assistant Manager QC Analytical Development & Drug Regulatory Affairs for Pharmaceutical IndustryJob Responsibility

  • Assay, Related Substances, Content, and Chiral method validation analysis as per ICH
guidelines and requirements.
  • Analytical method validation and method development.
  • Preparation of excel sheets for method validation results obtained for all of the above as per ICH
guidelines and requirements.
  • Handled the task of preparing the protocols before starting the validation as per ICH
guidelines and requirements.
  • Record Maintenance: To keep a complete and accurate record of all experiments and results in
form of laboratory notebooks.
  • Support to CRD team in routine analysis.
  • Experience in handling HPLC, UPLC, UV, etc.
  • Finished Product and In process Material Analysis.
  • Raw Material analysis.
  • Working Standard Preparation Analysis.
  • Preparation of Standard Testing Procedure.
  • Analysis of AMV Samples of Tablets and capsules, Injection or Eye drop.
  • Analysis of Stability Samples Tablets, Capsules Eye Drop, Oral Suspension, and injection.
  • Maintain Logbooks according to CGLP.
Technical Skills
  • Handling of Laboratory Instruments like UV /VIS Spectrophotometer (Shimadzu UV- 1700,1800)
  • Handling of HPLC (Shimadzu CHT 2010, LC 2030, Waters- e2695 with Empower 2&3
  • Handling of GC (Agilent 7890A, Shimadzu 2010 plus & 2014
  • Dissolution Apparatus, pH meter, Disintegration Apparatus, Friability Apparatus, Analytical Balance, etc.
For Drug Regulatory Affairs - Pharmaceutical Industry-In Regulatory AffairsDepartment:dossier preparation as per current prescribed guidelines for the national regulatory agency (for semi-regulatedmarketi.eAfricanCountries(Mali,Benin,Togo,Senegal,Cameroon,Congo, Chad, Guinee, Ivory Coast, Sierra Leone, Kenya, Uganda, Tanzania), ASEAN Countries (Cambodia, Myanmar, Philippines, Malaysia, Singapore, Vietnam, Brunei, Indonesia, Laos, Thailand).ii. Working on Pre & Post-registration of Dossier (compilation and preparation in CTD and ACTD format) and country-specific Dossiers for Yemen, Bolivia, etc.iii. Preparation of pharmaceutical/product development report as per the requirement based on the prescribed format.iv. Submission of the notification to the regulatory agency for the post-approval changes.v. Preparation and review of labeling information for compliance with regulatory requirements.vi. Variation filings for re-registered products in different countries.vii. Review and preparation of CMC (chemistry, manufacturing, and control) data for drafting module 3.viii. Communicating and requesting the documents from the QC/ QA departments and from the plant with manufacturing license/ WHO GMP certificate and COPP.ix. Review of documents like BMR (batch manufacturing record), MFR (Manufacturing formula record), stability data, Process validation, and analytical data, certificate of analysis, as per the specifications of API and FP (shelf-life specifications and shelf release specifications with their standard testing procedures (STP)).x. Understanding of ICH Quality and Efficacy guidelines.xi. Reviewing and understanding the requirements for container closure system (i.e. for primary and secondary packaging materials with standard testing procedures (STP) and standard testing specifications (STS)).xii. Follow up with the stakeholders to get corrected documents in line with review comments.xiii. Understand the use of orange data book for finding the use and functions of excipients.xiv. To prepare and assist in Q and Q (Quantitative and Qualitative) data required for the manufacturing of one tablet, capsule, ointments, gels, lotions, syrups, etc.xv. To Review the Analytical validation tests and procedures required for the formulation of tablets/ capsules (Dissolution, Disintegration), etc.xvi. Checking the Stability data (Accelerated Stability data, Long Term Stability Data, Intermediate Stability Data) and the parameter as per the specifications of the finished product.xvii. Reviewing the DMFs (Drug Master Files) of the API for the Manufacturer information, Certificate of Analysis, Specifications, etc.xviii. Assisted in responding to the queries generated by the vendor for already sent dossiers and updating the corrected documents for the same.xix. To file DMF/ANDA with regulatory agenciesIf interested Send Updated Resume at Email Id - hr.pawf@gmail.com,

Keyskills :
regulatory affairscontinuous improvement facilitationmisapiaccountssalesbankingph metermethod validationprocess validationdrug regulatory affairsanalytical developmentautomotive aftermarkettat

APPLY NOW

Assistant Manager QC Analytical Development & Drug Regulatory Affairs Related Jobs

© 2019 Hireejobs All Rights Reserved