Otsuka Pharmaceutical India Private Limited (OPI) resolutely believes in keeping its employees happy and spirited. We always strive to build conducive and lasting relationships with our employees and drive them in the direction of the utmost growth and development. Though oceans and desserts apart, all the Otsuka-people – a vigorous group of diverse professionals, are bound by a close-knit culture and driven by a common vision, sharing a common goal – bettering lives worldwide.
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Life at OPI goes beyond the realms of a routine job. Work is not about simply earning handsome salaries at OPI. It’s about being challenged every day, overcoming them, earning rewards, and achieving the biggest virtue of an employee, ‘Job satisfaction’. We encourage our people to broaden their horizon and steer their career in the direction of prosperity and success.
Training & Development, Engagement & Involvement form the foundational credo at OPI. Moreover, we keep our members engaged and motivated by inducing a value-based culture replete with youthfulness, openness, exuberance, goal-orientation, responsibility, excellence, ethics, pride to name a few by dint of our workplace practices.
Walk in Interview on 18th dec 2021 at AHMEDABAD
Location: Ahmedabad, Gujarat, India
- Execution of All IPQA related activities within the 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 online 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.
- Execution of All Process Validation related activities within the 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.
- To help in identification of any deviation and report further.
- To support in the investigation of any product deviation and Out of Specification (OOS).
- To suggest/recommend the changes in the Standard Operating Procedure (SOP).
- To help in the investigation of OOS and Documentation of the same.
- To be updated about the new changes in all international and local regulatory requirements.
- To monitor and implement the Good Manufacturing Practice (GMP) standards in the plant.
- To help in conducting monthly Corrective and Preventive Action (CAPA) meetings and preparation of CAPA summary report and gather CAPA details generated from individual quality sub-systems (e.g. Deviation, Change Control, OOS, Complaint, External inspection, Self-inspection).
For QC-Chemical Analysis(RM/PM & IPPT/FP):-
- To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
- To carry out the testing of Raw Material and Packing Material according to approved procedure.
- To release Raw Material and Packing Material.
- To carry out the calibration of instruments as per the schedule.
- To prepare the working standards as per the guidelines and various pharmacopeias.
- To ensure the status tag on the released material and transfer such material in the released area.
- To analyze the artworks as per the guidelines.
- To follow the Good Laboratory Practices and Good Manufacturing practices (GMP).
- To prepare requirement list of chemical & reagent for procurement.
- To perform the analysis of stability sample as per current specification.
- To compile the data required for internal quality audit in the plant, as and when required.
- To implement the cGMP standards.
- To ensure a clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
- To do a sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water, and pure steam.
- To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, chlorides, hardness, silt density index, and another testing as per the requirements.
- To analyze the samples of the water system after maintenance work.
- To observe and record the results of the microbiological plates and test tubes after analysis as well as supervise the discarding method of same.
- To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material samples as per the requirements and SOPs and record the results for the same.
Desired Candidate Profile:-
- Ready to work in rotational shifts.
- Excellent understanding of the 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.
Qualification: B.Sc, B.Pharma, MS, M.Sc, M.Pharma
Experience: 2-7 Years
Salary: 2,00,000 INR to 6,00,000 INR CTC/PA
Contact Details: firstname.lastname@example.org
Details of Walk-In
Date & Time: 18th December, 9.30 AM – 3.00 PM
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