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

Dy Mgr/ Mgr/ Sr Mgr- Quality For API Unit at Derabassi (Nr Chandigarh)

10.00 to 15.00 Years   Mohali   05 Jan, 2021
Akums Drugs & Pharmaceuticals Limited
Job LocationMohali
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

QUALITY MANAGEMENT SYSTEM:

  • Implementation of Quality Management System at site.
  • Ensure compliance to Current Good Manufacturing Practices (CGMP).
  • Overall responsible for compliance to in-house and contract projects with respect to Manufacturing.
  • Responsible for closing the OOS reports by providing proper technical justification including a suitable CAPA.
  • Responsible for performing product reviews.
TRAININGS:
  • Ensuring training to all employees as per the schedule and imparting training to shop floor personnel as well.
  • Reviewing the training records and assessment sheets
INTERNAL AUDITS:
  • Ensure that the internal audits (self-inspections) are performed as per the schedule.
  • Responsible to make sure that all the critical deviations are investigated and resolved.
SOPs and APPROVALS:
  • Responsible for approving all departmental SOP s.
  • Responsible for reviewing specifications of raw materials, in-process, intermediate and finished drug substances, packing materials, labeling materials and standard test procedures.
  • Responsible for approving process validation, cleaning validation, purified water system validation, HVAC, Hold time stability protocols and reports.
  • Review and approve qualification protocols of instrument/equipment, Analytical method transfer protocols and reports.
MANUFACTURING SUPPORT:
  • Responsible for reviewing and approval of scale-up, technology transfer and development reports.
  • Responsible for maintaining online documentation
  • Responsible for reviewing, identifying the gaps and support to complete the executed batch records
  • Responsible for reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution.
  • Responsible for releasing or rejecting all API s and Intermediates.
  • Responsible for approving intermediate and API contract manufacturers.
  • Responsible for approving changes that potentially impact intermediate or API quality.
OTHERS:
  • Responsible for acting as Quality Management Representative in the site.
  • Responsible for delegating works to In-Charge-QA in his absence.
  • REGULATORY/CUSTOMER AUDITS:
  • Responsible for all regulatory audits such as USFDA, EDQM, MHRA, KFDA, ANVISA, PMDA and TGA as a prime auditee.
  • Responsible for customer audits and ensuring to get minimum observations, specifically without any major/critical observations that may lead to data integrity.
  • Should able to handle the audits independently and is accountable to respond on all regulatory queries.
,

Keyskills :
soppurified waterapimethod transferinternal auditcustomer auditshisraw materialsprocess validationtgaoosregulatory auditsmusic makingquality managementmanagement systemquality management systemcontinuous improvement facilitationcleaning v

APPLY NOW

Dy Mgr/ Mgr/ Sr Mgr- Quality For API Unit at Derabassi (Nr Chandigarh) Related Jobs

© 2019 Hireejobs All Rights Reserved