Urgent Openings for Production / Quality Assurance / Plant Maintenance / Process Engineer @ Otsuka Pharmaceuticals

 

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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