Opening in Production (Parenteral) @ Otsuka Pharma, Ahmedabad
Experience: 1-6 yrs
Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm / Diploma
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.
- 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
- 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.
- 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.
- 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.
- 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 firstname.lastname@example.org