Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Apotex
Designation : Executive
Function : Quality Assurance
Functional Area : IPQA, Warehouse QA
Job Role Summary : IPQA activities, Warehouse QA activities, MMaR’ S / MPaR’s Review.
Job Profile :
  • Line clearance of Various in process stage such as Dispensing, Granulation, Compression, Coating, Packaging and Sampling.
  • In-process checks during manufacturing & packaging stage, Performance of AQL, collection of samples as applicable and trending of AQL.
  • Sampling of validation & commercial batch, Shelf life expiration date (SLED), Bulk completion date (BCD), sampling, Hold time study sample, In-process samples/Finished product samples, Collection, storage, and disposal of Reserve Sample.
  • Routine monitoring of all functional area to ensure adherence to the SOPs.
  • Create signature and methods for raw materials by using Truscan RM analyzer.
  • Approved / Rejected labels affixing for API, Excipients, Primary packing and secondary packing materials finished goods and operation supplies.
  • Verification of Temperature and Relative Humidity reports generated from TESTO software.
  • Co-ordination & ensuring timely execution of in-process activities for manufacturing and Packaging.
  • Swab/Rinse sampling for the cleaning verification & validation programme, cleaning & verification of sampling thief’s & accessories.
  • Co-ordination for in-house and external calibration.
  • Review of Master Manufacturing Records & Master Packing records & logbooks.
  • Utilize your networks to attract and hire talent in a comprehensive, differentiated, and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
Job Requirements :
  • Minimum 02 Years of experience in GMP Regulated Pharmaceutical industry.
  • Should possess good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet
     
Work / Job Experience : 2 Years
Type of Experience : Pharma IPQA, Line clearance, Inprocess Checks
Academic Qualifications :

Bachelor of Pharmacy/ Science or any equivalent degree.

Website Linkedin Apotex

To apply for this job please visit careers.apotex.com.