
Qa Executive
2 days ago
ARKRAY Healthcare Pvt. Ltd. Surat, India
Document Control OP/F/046, Ver. 01, Effective date: , Due date:
Job Description
(Reference Procedure: OP/S/001)
JD No.JD-QLT-022Organization Level Division / Department / Team / Supervisor / Team MemberJob TitleExecutive ILJob PurposeCarries out monthly testing of finished products of serology & microbiology products and manage Quality Control Activity in Arkray Healthcare Pvt Ltd. Job ImportanceDay to day observation of test for sterility and recoding the same.Job Responsibilities
- Ensuring that all raw materials (ROH), packing materials (VERP) are tested in time (as per TAT) and release as per the approved quality specs/documents.
- Ensuring that all the in process (IPQC) and semi-finished products (HALB) are tested in time (as per TAT) and release as per the approved quality specs/documents.
- Ensuring that all the finished products (FERT) are tested in time (as per TAT) and release as per the approved quality specs/documents.
- Ensuring periodic conduction of calibration, testing and measuring instruments/equipment as per schedule in the section.
- Prepare and standardize the lab use reagents.
- Assisting Asst. Manager/Section Head in adherence to the regulatory and FDA audit process (internal and external).
- Ensuring for timely completion of different types of stability (Real Time, Accelerated Transport Stability/In use Stability) for various stages of materials/reagents/finished product in the section.
- Assisting Asst. Manager/Section Head for new vendor or alternative vendor development activity in the section.
- Ensuring of QC area (cold rooms, deep freezers, incubators, laboratory) as per GMP compliance.
- Ensuring records are filled properly, stored properly and easily retrievable.
- Assisting Manager QC/Asst. Manager/Section Head for microbiology work like sterility test and work related to prepare before sterility test. Identification of organisms.
- All other activities as and when required by superior.
Job Authority
- Authorized to do Various Types of sampling, Testing and Releasing (ROH / VEPR / INP / HALB / FERT / HAWA) as per std. TAT (SQ/TR/023).
- Authorized to do Lab use Reagent / Buffer preparation (SQ/TR/026).
- Authorized to use Different Types Incubators / Oven / Water Bath and Freezers Handling (SQ/TR/028).
- Review of plan, protocol and report of study conducted by QC.
Candidate Requirements
- Should have good knowledge about product.
- Good communication skills verbal as well as written.
- Good Team Player with proactive approach and experience of working in Cross Functional Teams (CFT).
LocationARKRAY Healthcare Pvt. Ltd. Plot No , Road No. 3, GIDC- Sachin, Surat , Gujarat, IndiaTravelling RequirementsNo QualificationM.Sc / B.Sc
(Prepared By)
HRGA Team Manager(Reviewed By)
Reporting Manager(Approved By)
HRGA Department ManagerNameShaligram DodiaRajesh PancholiShaligram DodiaSign & Date
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