Hetero Labs Limited – Walk-In REGULATORY AFFAIRS on 20th May 2023

Hetero -Walk in

Qualification: B.Pharm, M.Pharm

Experience : 02-08+years
Department: REGULATORY AFFAIRS

Job Location: Hyderabad/Secunderabad

Time and Venue

Interview date: 20th May 2023 (Saturday) Time: 9.00 a.m. to 3.00 p.m.

Venue: Hetero Labs Limited, Unit VII

Plot:No; 14, Jeedimetla, Qutubullapur(M), Medchal Dist., Hyderabad. T.S

E-mail: [email protected] for further info.

Job Description

Keen Knowledge on Regulatory guidelines for finished product registration.

Compilation and review the product dossiers for submission in CTD, ACTD.
Gap analysis of the dossier and addressing the gaps before submission to MOH.
Handling the customer and MOH queries.

Life cycle management of the product.
Compilation and Submission of ANDA’s & EU dossiers.
Post & Pre approval experience to file the applicable variations timely.

Knowledge on EU, ICH and EMEA guidelines.

Post Views: 581

About the Author

By shivpharma2016

May 19, 2023

Created on August 07, 2023 By

shivpharma2016

IPQA Interview Question Quiz 1

In Process Quality Assurance, IPQA is very important in any manufacturing of pharmaceutical Industries, primary role is to ensure that the manufacturing process adheres to cGMP guidelines and follows the approved standard operating procedures. also, review batch records and documentation to ensure accuracy and completeness. The Main Objective of IPQA is to maintain product quality and ensure that all finished products meet the required specifications

1 / 10

Question 1: What is the primary responsibility of an IPQA officer in the pharmaceutical manufacturing process?

To ensuring compliance with cGMP guidelines and approved procedures during manufacturing.

To ensure that the vendor's quality management system (QMS) meets business requirements and standards

For building Management

For new employee recruitment

2 / 10

Question 2: Which department is responsible for conducting in-process checks and inspections in a pharmaceutical manufacturing facility?

In-Process Quality Assurance (IPQA) department.

Warehouse Department

Engineering Department

None

3 / 10

Question 3: What is the purpose of conducting line clearance before starting a new batch or product?

To ensure that the production area and equipment are free from any residues or materials from the previous batch.

To ensure the equipment qualification

For Inventory Control

For finished Product testing

4 / 10

Question 4: Which approach is used to monitor critical process parameters and identify process instability?

Statistical Process Control (SPC) methods

Line clearances of manufacturing activity

Online Sampling

Online Documentation

5 / 10

Question 5: What is the role of an IPQA officer during batch release activities?

Reviewing relevant documentation to ensure the production process adhered to approved procedures and that the product meets quality standards.

Planning and projection of various raw materials and consumables requirement of the department

Timely complete all the Civil work of facility to ensure the all building look like new and good

Reviewing relevant Cleaning validation documentation to ensure the cleaning procedure is capable to effective cleaning of equipment and facility

6 / 10

Question 6: What action should an IPQA officer take when identifying a deviation in the manufacturing process?

Immediately halt the affected process and initiate a deviation report.

Immediately informed to respective supervisor / In-charge to officer and above of Quality assurance department

Both of the above

None

7 / 10

Question 7: What does "cGMP" stand for in the pharmaceutical industry?

Current Good Manufacturing Practices.

Clinical Good Manufacturing Practices.

Current Good Management Practices.

Current Good Management Procedure.

8 / 10

Question 8: How do IPQA officers verify equipment used during the manufacturing process is properly calibrated?

Reviewing calibration records to ensure compliance with the schedule.

Reviewing calibration tags on instruments/equipment to ensure compliance

Both of the above

None

9 / 10

Question 9: Why do we calibrate an instrument at a particular interval?

Because it can be possible for instruments to drift out of accuracy after qualification

Because it is used in manufacturing

Because it is product requirement

Because it is customer requirement

10 / 10

Question 10: What is the purpose of conducting changeover verification procedures in manufacturing?

To prevent cross-contamination and ensure product integrity during the transition from one product to another.

To and smooth dispensing and manufacturing

To easy and smooth dispensing and Packing

None

Your score is

The average score is 72%

Hetero Labs Limited – Walk-In REGULATORY AFFAIRS on 20th May 2023

Hetero Labs Limited – Walk-In REGULATORY AFFAIRS on 20th May 2023

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