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

Analytical QA -API Pharma -Mysore

8.00 to 10.00 Years   Mysore   14 Dec, 2020
Classic Search Pvt Ltd
Job LocationMysore
EducationNot Mentioned
SalaryNot Disclosed
IndustryRecruitment Services
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Roles and Responsibilities

  1. Review of analytical data generated during different analytical testing
  2. Review of batch release documentation, analytical protocols for analytical method validation, method transfer and process validation
  3. Review of daily calibration data and Internal audit of laboratory and QC SOPs.
  4. Conduct risk assessment for analytical activities and enforce SOPs
  5. Preparation and review of laboratory incidents, OOS and OOT reports.
  6. Review of laboratory computer system validations as per GAMP guideline and Instrument Qualification documents in line with regulatory requirements
  7. Preparation and review of Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports.
  8. Writing analytical specifications using current pharmacopoeias and reviewing existing analytical specifications.
  9. Supporting all QC activities for review and timely release of test reports.
Desired Candidate Profile
  1. Exposure to regulatory inspections like USFDA, EDQM
  2. Knowledge and hands on experience on QMS documentation like change control, lab incidents, OOS, OOT, investigations.
  3. Awareness of 21 CFR part 11 requirements including User Management Policies, audit trail review etc.
  4. Hands on experience in sophisticated instruments like HPLC, GC, GC-MS, Malvern, TOC for testing of sample for Purity, impurity etc.
  5. Experience to work on Quality management software like SAP, Track wise, LIMS etc
  6. Candidate should possess managerial skills and team building capability
  7. Green field facility system development experience will be preferable.
  8. M.Sc Chemistry(Organic,Analytical)
Perks and Benefits,

Keyskills :
analytical method validationaudit trailteam buildingbatch releaserisk assessmentuser managementmethod transfermethod validationprocess validationanalytical testingsapqmsoosootcfrrisklimsedqm

APPLY NOW

Analytical QA -API Pharma -Mysore Related Jobs

© 2019 Hireejobs All Rights Reserved