Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan, for Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segments. Being a leader in intravenous nutrition products, we are committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition..

Time and Venue:

Job description:

For QA(IPQA/Validation/QMS):-

• 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.
• 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.
• To help in identification of any deviation and report further.
• To support in investigation of any product deviation and Out of Specification (OOS).
• To suggest / recommend the changes in the Standard Operating Procedure (SOP).
• To help in 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 CQA:-

• Handling of Quality Management Systems i.e. deviations, incidents, change management system, CAPA, out of specification (OOS), risk management, internal quality audit,
• Quality Management SOP and training module preparation.
• To maintain records, reports and logbooks.
• Perform risk assessment for changes to be carried out in pre-defined documents.
• Issuance of formats for record purpose as per requirement.
• Acceptance of change control notes after consultation with superiors.
• Attend GMP and GDP training as per training schedule.
• Co-ordinate with plant departments regarding documents requirement.
• To carry out investigation and preparation of investigation report.
• To prepare and review the data, analysis report and other supporting document, related to product query.
• To prepare quality agreements as applicable for various contract parties.
• To organize internal audits as per SOP in line with the audit schedule.
• To follow up with concerned persons for generation and closure of CAPA related to observations made during audits.

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 pharmacopoeias.
• 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.

For QC-Micro:-

• To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
• To do 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 other testing as per the requirements.
• To analyze the samples of water system after maintenance work .
• To observe and record the results the microbiological plates and test tubes after analysis as well as supervise discarding method of same.
• To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material sample as per the requirements and SOPs and record the results for the same.

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.

The above positions are for experienced candidates and for rotational shifts only. Fresher candidates have to share their resume on hrm.opmf-amd@otsukapharma.in