QC/QA - Executive Senior Executive

2 - 5 years

3 - 7 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

Open Functions: Quality Control/Quality Assurance

Experience Required:

Job Titles & Grades: Executive / Sr. Executive (based on experience)

QC

  • Routine & stability testing of RM / IP / FP samples on HPLC, GC, LCMS, UV, etc.
  • Prepare/standardize analytical methods, calibration & instrument qualification (IQ/OQ/PQ)
  • Adhere to GDP, ALCOA+ and cGMP guidelines; ensure timely LIMS/SAP data entry
  • Investigate OOS/OOT results and implement effective CAPA
  • Support regulatory, customer and internal audits

QA

1. Handling of market complaints.

2. To acknowledge the complaints to the reporter

3. conducting complaint Investigations

4. Co-ordinate with functional investigators (Cross Functional Team/Subject Matter Experts) for timely completion of complaint investigations.

5. Follow up for complaints closure letter from the Reporter and close the complaint in complaints closure form.

6. Involve in root cause analysis, Failure Investigations and Risk assessment activities.

7. Initiate, review of Corrective action & preventive action and To prepare trend of complaints.

8.To Maintain all the Quality management system documentations.

Common Requirements:

  • Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry or related)
  • Sound knowledge of current GMP guidelines (US-FDA, MHRA, EU, WHO)
  • Good documentation, investigation and communication skills
  • Willingness to work in shifts and collaborate with cross-functional teams

For further information:

  • Send you updated resume :

    naidupetahr@aurobindo.com


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Aurobindo Pharma logo
Aurobindo Pharma

Pharmaceuticals

Hyderabad

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