Walk-in on 10th June for QA/QC/IPQA/QMS | Otsuka Pharma | Ahmedabad

Job Description

Walk-in on 10th June for QA/QC/IPQA/QMS

For QA/CQA(IPQA/Validation/QMS):

• 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, and qualification planner.
• Conduct Material issuance for validation activities.
• Sample withdrawal during process validation.
• Record observations in observation sheets for process validation.
• Coordinate and execute process validation, and qualification activities & inform about deviations from planning.
• New equipment qualification & validation.
• To help in the 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 reports 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 Materials and Packing Materials according to the 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 a requirement list of chemicals & reagents for procurement.
• To perform the analysis of the 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 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 the 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.

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.

Note: The above positions are for shift (rotational) operations and only for experienced candidates. Fresher candidates have to share their resumes through Apply Now Option

Qualification: B.Sc./M.Sc./B.Pharm./M.Pharm

Walk-in Details

Date & Time: 10th June , 9.30 AM – 3.00 PM

Venue:

Otsuka Pharmaceutical India Pvt Ltd

21st Floor, B-Block, Westgate, Nr. YMCA,

S.G Highway,

Ahmedabad – 380 015