Otsuka Pharmaceutical Walk-in on 10th June 2023 For B.Pharm, M.Pharm, B.Sc, MS/M.Sc

Otsuka Pharmaceutical -Walk-in on 10th June 2023 For B.Pharm, M.Pharm, B.Sc, MS/M.Sc

Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan, for Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segments. Being a leader in intravenous nutrition products, we are committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition..

Otsuka Pharmaceutical Walk-in Interview

Qualification: B.Pharm, M.Pharm, B.Sc, MS/M.Sc

Experience : 02-07+years
Department: QA/CQA/QC
Job Location: Ahmedabad( Moraiya )

Time and Venue:

10th June , 9.30 AM – 3.00 PM

Otsuka Pharmaceutical India Pvt Ltd 21st Floor, B-Block, Westgate, Nr. YMCA, S.G Highway, Ahmedabad – 380 015

Contact – Team HR

Job description:

For QA/CQA(IPQA/Validation/QMS):-

Execution of All IPQA related activities within manufacturing unit.
Line clearance, in-process dispensing and sampling activities.

BMR/BPR issuance, review and preparation under the guidance of seniors.
Issuance of Standard Formats and submitting the documents.
Preparation of SOP as per the current organization norms and cGMP guidelines under the observation of seniors.

Execute routine IPQA monitoring.
Review and approve on-line documentation of manufacturing, testing and packing activity.
Investigation of any deviation / abnormal observation.

Review the GDP issues in Production / QC / QA and in logbooks.
Execute CAPA defined by management/QMS.
Review critical quality attributes of products, review trend analysis and keep track of OOT results.

Execution of All Process Validation related activities within manufacturing unit.
Review process validation, qualification planner.
Conduct Material issuance for validations activities.

Sample withdrawal during process validation.
Record observations in observation sheets for process validation.
Coordinate and execute process validation, qualification activities & inform about deviation from planning.

New equipment qualification & validation.
To help in identification of any deviation and report further.
To support in investigation of any product deviation and Out of Specification (OOS).

To suggest / recommend the changes in the Standard Operating Procedure (SOP).
To help in investigation of OOS and Documentation of the same.
To be updated about the new changes in all international and local regulatory requirements.

To monitor and implement the Good Manufacturing Practice (GMP) standards in the plant.
To help in conducting monthly Corrective and Preventive Action (CAPA) meetings and preparation of CAPA summary report and gather CAPA details generated from individual quality sub-systems (e.g. Deviation, Change Control, OOS, Complaint, External inspection, Self-inspection).

For QC-Chemical Analysis(RM/PM & IPPT/FP):-

To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
To carry out the testing of Raw Material and Packing Material according to approved procedure.
To release Raw Material and Packing Material.

To carry out the calibration of instruments as per the schedule.
To prepare the working standards as per the guidelines and various pharmacopoeias.
To ensure the status tag on the released material and transfer such material in the released area.

To analyze the artworks as per the guidelines.
To follow the Good Laboratory practices and Good Manufacturing practices (GMP).
To prepare requirement list of chemical & reagent for procurement.

To perform the analysis of stability sample as per current specification.
To compile the data required for internal quality audit in the plant, as and when required.
To implement the cGMP standards.

For QC-Micro:-

To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
To do sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water and pure steam.

To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, chlorides, hardness, silt density index and other testing as per the requirements.
To analyze the samples of water system after maintenance work .
To observe and record the results the microbiological plates and test tubes after analysis as well as supervise discarding method of same.

To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material sample as per the requirements and SOPs and record the results for the same.

Candidate Profile :-

Ready to work in rotational shifts.

Excellent understanding about working area.
Initiator and Learner.
Decision making ability.

Team player and if required, can provide training to other team members.
Good communication.
Exposure in Parenteral Formulation.

Note: The above positions are for shift (rotational) operations and only for experienced candidates. Fresher candidates have to share their resume on [email protected]

Post Views: 678

About the Author

By shivpharma2016

June 8, 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%

Otsuka Pharmaceutical Walk-in on 10th June 2023 For B.Pharm, M.Pharm, B.Sc, MS/M.Sc

Otsuka Pharmaceutical -Walk-in on 10th June 2023 For B.Pharm, M.Pharm, B.Sc, MS/M.Sc

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