Walk-In Interview @ Otsuka Pharmaceutical, Ahmedabad On 09th Dec’ 23
Experience: 2 – 7 Years
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
Time and venue:
09th Dec, 9.30 AM – 3.00 PM
Otsuka Pharmaceutical India Pvt. Ltd. 21st Floor, B-Block, Westgate, Nr. YMCA, S.G. Highway, Ahmedabad, Gujarat – 380 015
Contact – Team HR
