Otsuka Pharmaceutical – Walk-In Interview on 28th Aug’ 2022 for Production / Packing / QA / QC / QC-Micro

In keeping with our corporate philosophy, “Otsuka-people creating new products for better health worldwide,” and the Otsuka values of Ryukan-godo (by sweat we recognize the way), Jissho (actualization), and Sozosei (creativity), we strive every day to do what only Otsuka can do. In this way, the Otsuka group contributes to the lives of people worldwide through innovative and creative products and services including pharmaceuticals, functional beverages and functional foods.

Vacancy Detail

For Production (Parenteral/Injectable exposure only):

Process In-charge: (B.Sc./M.Sc./B.Pharm./M.Pharm.)

1. – To ensure the cleanliness, environmental norms and other process of various area like Dispensing, Mixing, Filling and Terminal Sterilizer.
2. -To complete CIP, SIP and batch manufacturing process timely.
3. -To ensure the batch manufacturing process is done as per Batch Manufacturing record.
4. -To co-ordinate with other departments like QA, QC, Stores, Engineering, etc. as and when required.

Associate (Machine Operator): (ITI/Diploma)

1. -To monitor temperature / humidity of clean rooms, and if any deviation is found, inform the Engineering department.
2. -To ensure cleaning and disinfections of floor, ceiling, wall, pipeline, vessels and equipment as per frequency defined.
3. -To maintain the cleaning and lubrication of machine regularly.
4. -To ensure the machine is working smoothly and it is performing well.

For Packing (Parenteral/Injectable exposure only):

Process In-charge: (B.Sc./M.Sc./B.Pharm.)

1. –To make sure that issued material is as per requirement and the material quality is as per specification.
2. -To check the availability of packing material with proper labels and status.
3. -To ensure that the packing activity does not start without line clearance.
4. -To check, verify and destroy the rejection generated during packing and ensure recording of all such material.
5. -To update the Batch Packing Record on line.
6. -To check the packing online at frequent intervals as defined in the Standard Operating Procedure.
7. -To train personnel for the critical operations like visual inspection and labeling.

Associate (Machine Operator): (ITI/Diploma)

1. -To maintain the machine in good condition by regular cleaning and lubrication.
2. -To ensure that machines are working smoothly and performing as per standards.
3. -To supervise the packing activities online at frequent intervals as defined in the Standard Operating Procedure (SOP).
4. -To ensure that the machine/s are started within time period & perform challenging test.

For QA(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.

The above positions are for experienced candidates and for rotational shifts only. Fresher candidates have to share their resume on hrm.opmf-amd@otsukapharma.in