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Otsuka Pharma Ahmedabad jobs for Production Quality Assurance Maintenance Process Engineer apply now 

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Otsuka Pharmaceuticals - Urgent Openings for Production / Quality Assurance / Plant Maintenance / Process Engineer Department at Ahmedabad  

Opening in Production (Parenteral) @ Otsuka Pharma, Ahmedabad

Experience: 1-6 yrs

Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm / Diploma

Job description:

For Process Incharge:
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·                   To ensure the cleanliness and environmental norms of various area like dispensing, compounding, filling, capping, including airlocks .

·                   To ensure cleaning and disinfection of floor, ceiling, wall and equipments.

·                   To ensure that the maintenance of dispensing compounding, filling, capping, including airlocks is as per Standard Operating Procedure (SOP) norms.

·                   To carry out planning of material issue and dispensing as per priority of batch manufacturing.

·                   To prepare documents regarding material issue and dispensing.

·                   To issue the material from store as per Batch Manufacturing Record.

·                   To ensure the batch manufacturing process is done as per Batch Manufacturing record.

·                   To control the timing of Cleaning In Process (CIP) / Sterile In Process (SIP) and batch manufacturing process, to start the production timely.

·                   To do the Bubble Point Test (BPT) / Forward Flow Test (FFT) of product filter before and after filtration and Water Intrusion Test (WIT) of air filters.
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For Machine Operator:-

·                   To monitor temperature / humidity of clean rooms, and if any deviation is found, inform the Engineering department.

·                   To ensure cleaning and disinfections of floor, ceiling, wall, pipeline, vessels and equipment as per frequency defined.

·                   To ensure cleanliness of airlocks after entry and exit of the workers.

·                   To maintain the cleaning and lubrication of machine regularly.

·                   To ensure the machine is working smoothly and it is performing well.

·                   To check the equipment after preventive maintenance and if found any dissatisfaction, ensure not to start further process.

·                   To ensure that the preventive maintenance of machine is performed regularly and timely.

·                   To maintain the machine in good condition by regular cleaning and lubrication.
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·                   To ensure proper gowning of personnel working in clean room.

·                   To ensure follow up of Standard Operating Procedure (SOP) during entry / exit from clean room.

·                   To ensure cleaning and steaming process is carried out as per validated procedure.

·                   To do the replacement of change parts and trial of machine within the time limit.

Candidate Profile:-

·                   Qualified and experienced candidates for our Manufacturing operations (LVP).

·                   Good communication skill and exposure in Parental formulations.

·                   Open to work in shifts.

·                   Team leader skills.

·                   Proper decision making abilities.

·                   For Machine Operator minimum qualification should be ITI.
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Opening in Quality Assurance (Parenteral) @ Otsuka Pharma, Ahmedabad

Experience: 1-5 yrs

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

For IPQA:-

·                   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.
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·                   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.

·                   To review Preventive Maintenance, Breakdown maintenance and perform risk assessment, suggest immediate corrective actions, report conclusion of the same.

·                   To maintain stability general quarantine area/ record and issue stability batch samples in case of any requirement received.

For QA-Process Validation:-
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·                   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.

Candidate Profile:-

·                   Ready to work in rotational shifts.

·                   Excellent understanding about working area.
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·                   Initiator and Learner.

·                   Decision Making ability.

·                   Team player and if required, can provide training to other team members.

·                   Good communication.

·                   Exposure in Parenteral Formulation.

Opening- Plant Maintenance/ Process Engineer, Otsuka Pharma, Ahmedabad

Experience: 1-6 yrs

Qualification: B.E / B.Tech / M.Tech

Knowledge of Maintenance system like:-

·                   Preventive maintenance, Breakdown maintenance, Spare planning, history records & SAP system.
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·                   Knowledge of GDP and GEP.

·                   Preferable Pharma background knowledge.

·                   Exposure in Technology like, BFS, FFS.

·                   Hands on equipment like Autoclave, Washing & Tunnel, and Lyophilizer, Leak testing machine, Visual inspection machine, Labeling machine.

·                   Terminal sterilizer.

·                   Water system ( RO, WFI, PSG)

·                   Packing line.

Technical Skill:-

·                   Knowledge of PLC, SCADA & Control system
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·                   Automation instrument: Drives, Servo system, vision system, sensors etc.

·                   Knowledge of Pneumatic & Hydraulic system.

·                   Documentation as per Pharma guideline.

Candidate Profile:-

Well qualified and experienced candidates for our Manufacturing operations. Candidates possessing good communication skill and exposure in Parental formulations.

Interested candidates can share their resume on hrm.opmf-amd@otsukapharma.in

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