Executive / Sr. Executive - Quality Control (Injectables), Formulation

By: Pharma Jobs | Views: 3801 | Date: 18-Jul-2011

Job detail for the post of Executive / Sr. Executive - Quality Control (Injectables), Formulation in Aurobindo Pharma Ltd Hyderabad / Secunderabad, 2 to 5 years of experience. Apply for the job Now ! Search Jobs in India by Functional Area, Industry and Location. Search Jobs in India - Delhi, Mumbai, Bangalore, Kolkata. Find career openings in top companies. Post your resume and find your dream job Now !.

5 Opening(s) Aurobindo Pharma Ltd
 
Experience:

2 - 5 Years

Location:

Hyderabad / Secunderabad

Compensation:

As per company norms

Education:

UG - B.Pharma - Pharmacy PG - M.Pharma - Pharmacy,M.Sc - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

QA/QC Exec.

Functional Area:

Production, Maintenance, Quality

Posted Date:

18 Jul

Desired Candidate Profile

 To check all the activities and maintain the GLP in the department.

To check the analyst trained in QC/General procedures and update the training records. Analyst qualification before starting activity in the lab.

To check and review the stability protocols. Stability data compilation.

To perform the online documentation activity.

Experience in QC injectable facility.

Good audit exposures (USFDA, UKMHRA, WHO etc.)

Preparation of SOP’s and GTP’s as the regulatory requirements.

Maintenance of all records as per the USFDA and MHRA.

 

Job Description

 

Sr. Executive Job:

Responsibilities:

1) To check all the activities and maintain the GLP in the department.

2) To check the stability samples received from the IPQA as per the protocol. Charging and withdrawal of stability samples, daily temperature monitoring and maintenance of stability chambers.

3) To check the analyst trained in QC/General procedures and update the training records. Analyst qualification before starting activity in the lab.

4) To check the approval of preparation of stability protocol and worksheet. daily planning of analysis of stability and stability protocol and worksheets.

5) Stability samples as per month wise planning. Daily monitoring of stability ongoing samples. Destruction samples after analysis. Maintenance of stability protocols.

6) To check the calibration and validation of stability chamber. Stability chambers excursions during the working conditions.

7) To check online and review of the stability documents. Stability trend results.

8) To solve the trouble shouting to the analytical issues. Entire SOP’S related to QC/Stability department has following.

9) To initiate the OOS, OOT, Incidents, Deviations, Change control, other related issues of stability.

10) To check and review the stability chambers daily monitoring records. Stability procurements with respect to specifications/STP & GTPs.

11) To check and review the stability protocols. Stability data compilation.

Executive Job:

Responsibilities:

1. To perform the analysis of finished and stability samples.

2. To perform the online documentation activity.

3. To perform the Charging and withdrawal of stability samples.

4. To execute Daily Temperature monitoring and maintenance of stability chambers.

5. Getting trained in QC/General procedures and update the training records.

6. To carry out maintain the GLP activities in the Lab.

7. Preparation of stability protocol and worksheets.

8. To maintain the stability ongoing samples, destruction samples and charging of samples.

9. To continuation of stability records. To execute the destruction of samples after analysis.

 

 

Keywords: injectable quality control qc

Company Profile

Aurobindo is among the largest 'Vertically Integrated' pharmaceutical companies in India with robust product portfolio spread over major product areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics, Gastroenterologicals, Anti-Diabetics and Anti-Allergic with approved manufacturing facilities by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-Brazil for both APIs & Formulations and has Global presence with own infrastructure, strategic alliances, subsidiaries & joint ventures.
Contact Details
Company Name:

Aurobindo Pharma Ltd

Website:

http://www.aurobindo.com

Executive Name:

K.R.Srinivas

Address:

Not Mentioned

Telephone:

040-23040261

Reference ID:

QCEXEINJU4

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Comments
kamranchemist  |  03-Dec-2013 17:08:06 IST
please share questions and answers on sterile manufacturing.
thanks
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