Manager – QA

5 - 10 Years
Hyderabad

Job Description

Roles and responsibilities:
  • He is responsible to the management for maintaining quality system in the organization
  • To work in coordination with Asst.Manager-/QA and Officer-QA
  • He is responsible for implementing quality systems as per ICH guideline which includes approving of all documents like SOPs
  • Impart training to all sections on ICH guideline, GMP, cGMP as per the training SOP
  • To control all documents through document control and documentation
  • To control all major changes through change control and documentation
  • To approving the prospective vendors according to vendor approval procedure by following SOP
  • Monitor the maintenance of various departmental records as per the regulatory requirements
  • Conduct internal audits and cGMP inspection and monitor
  • To review and approve all quality related documents such as specifications, test methods, test protocols pertaining to the quality control department
  • Review the Batch releases and product release to the market
  • To comply with regulatory requirements
  • To ensure critical deviations are investigated and resolved
  • OOS results and customer complaints
  • To establish a change control system that would evaluate all changes that may potentially affect the quality of the API or intermediate
  • Responsible to recall the product/ batch if found unsafe or deleterious to the customer/ patient and to inform unit head, statutory authorities
  • Follow up with Regulatory Audits and Customer Audits
  • Reviewing all Regulatory Dossiers prior to submission to Regulatory Affairs Department
  • To perform product quality reviews (Annual product reviews), analysis of failures (Out of specifications), faults and deviations including changes and come up with corrective action in co-ordination with relevant department, to monitor the same for effective implementation, generate trend analysis for the finished product

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Production, Manufacturing, Maintenance

Role Category:Production/Manufacturing/Maintenance

Role:Quality Assurance/Quality Control Manager

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Company Profile

GOALREIFY VENTURES PVT LTD

We are a young and dynamic team of head hunters with 8+ years of experience. Our team has helped many clients based out of MENA & APAC region in finding the passionate talent in their journey of success. With the blend of innovative approach and passion towards recruitment, out team has successfully carried out many niche assignments.
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Contact Company:GOALREIFY VENTURES PVT LTD

Email :varsha@goalreify.com

Reference Id:1819161