Meyer Organics Urgent Opening for QA-Regulatory Affairs,QC

Meyer Organics is hiring in QA-Regulatory Affairs,QC.We think harder to make healthcare simple Welcome to MEYER Organics – India’s one of the leading pharmaceutical manufacturer, founded in 1982 in technical collaboration with OMEGA – MEYER Ltd., Jersey ( Br. Isles).Interested and eligible candidates can share resume at divya@meyer.co.in

Vacancy Details :

  • Company Name: Meyer Organics
  • Location : Bengaluru
  • Post Name: QA-Regulatory Affairs /QC
  • Qualification: B.Pharmacy/ M.Pharmacy/M.sc/B.sc
  • Experience: 0 – 6 years
  • No of Vacancies: 01
  • Details of Salary: 2,00,000 – 3,50,000 P.A.
  • Contact: Divya S
  • Mode of application : Online
  • Selection Process: Personal interview

Job Description/Skills Required :

Hiring For QA-Regulatory Affairs /QC in Meyer Organics Pvt. Ltd! If interested candidates can share your resume to mentioned mail ID divya@meyer.co.in

QA-Regulatory Affairs

1. Line clearance ( Liquid Oral , Tablets , Capsules)
2. Responsible for monitoring In-process quality control checks in manufacturing department.
3. Comparing the description for all products against the standards.
4. Collection of samples stage wise for analysis and handover for QC Testing.
5. Checking any OOS recorded during online process and reporting to seniors.
6. Final BMR reconciliation before release for packing.
7. Preparation of Process Validation protocol & Flow charts of Tablets.
8. Preparation of presentation of products that are manufactured as a part of training.
9.To stop the line in case of any non compliance and with proper approval and guidance from seniors and HOD.
10.To reconcile the BMR and handover the final BMR for closure.

11.To know cGMP guidelines.

REGULATORY

1. Handling of documents for Export / Import NOCs.

2. Handling of documents for Additional Product Permissions.

3. Handling of documents for Certifications GMP, CoPP, FSC, NC, Capacity, Market Standing, GLP, Test Licence, CTS.

4. Knowledge about online portals of DCGI / SLA – SEVASINDHU / IDMLA / e-SUGAM.

5. Handling of documents for FSSAI licensing and Certifications with State FSSAI & Central FSSAI.

6. Handling of documents for WHO-GMP application and certifications.

7. Reviewing Stability / Validation protocols and reports.

QC Department

  1. Complete Quality Control operational requirements by scheduling and assigning employees; following up on work results.
  2. Maintain Quality Control staff job results by coaching, counseling and disciplining employees; planning, monitoring and appraising job results.
  3. Handling entire activities under the section Quality Control Wet analysis / Instrumentation , Stability and Microbiology.
  4. ERP Entries -Item master specification, Updating for RM/PM/FP/BULK COA authorization for RM/FP/PM/BULK
  5. Vendor interaction in case of quality issues and requirement.
  6. Co ordination for external services, calibration, equipment requirements & AMC Compliance.
  7. Handling all Quality Control department activities.

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