Otsuka Pharmaceuticals - Urgent Openings for Production / Quality Assurance / Plant Maintenance / Process Engineer - Apply Now

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:-

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.

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.
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.

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.
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:-

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.
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.
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
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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