Otsuka Pharmaceuticals urgent job openings for Production, QA, Plant Maintenance, Process Engineer

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
Job Description:
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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