Otsuka Pharmaceutical Walk-In Interview for QA( IPQA/QMS) / QC / QC-Micro / ADL

Otsuka Pharmaceutical  Walk-In Interview for QA( IPQA/QMS) / QC / QC-Micro / ADL

Otsuka Pharmaceutical  Walk-In Interview for QA( IPQA/QMS) / QC / QC-Micro / ADL

Walk-in Interview @ Otsuka Pharmaceutical, Ahmedabad on 14th Aug ’2021

Date: 14th August, 2021

Time: 9.30 AM – 3.00 PM

Venue:

Otsuka Pharmaceutical India Pvt. Ltd.

21st Floor, B-Block, Westgate, Nr. YMCA, S.G. Highway,

Ahmedabad, Gujarat – 380 015

Job description:

For QA(IPQA/Validation/QMS/Doc Cell):-

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).

2) 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.

3) 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.

4. For ADL:

Responsible for Analytical Method Validation and Method Development activity.

To perform F&D sample analysis.

Responsible for Good Lab Practices (GLP) activities and its complies.

Responsible for Calibration of lab instruments.

Preparation and review of Validation Protocols/Reports and Analytical Reports including data.

Preparation/Review of SOP and its compliance.

Responsible for Procurement of analytical and Lab requirements.

To maintain the Documents of Analytical Protocols and Reports including Validation and Development.

Responsible for maintain the stock of Laboratory requirements including chemicals and other analytical requirements.

To maintain all data and log book records with Online as per GLP Requirement.

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.

Otsuka Pharmaceutical Walk-In Interview for QA( IPQA/QMS) / QC / QC-Micro / ADL