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Job Description

Reviewing complete batch production and laboratory control record of critical process steps as per checklist and handover to Manager - QA for final approval

Responsible to issue and retrieval of the batch manufacturing records

Responsible to prepare all Specs., BMR's and BPR's

Responsible for training schedule and inform concern dept, regarding training.

Responsible for control of Quality records

Responsible to organise training schedules

Responsible to prepare annual product review report

Responsible to prepare water trend reports

Responsible to implement all procedures within the organisation

Responsible for handling of Non Confirming product, incidents, deviations etc.

Responsible to IPQA Activities and review of all quality related documents like BMR & BPR, PTC, Release slips etc,

RA:

Advise and notify the management & all the concerned of changes in legal and statutory aspects of India, and in the regions in which the compay & its subsidiaries wish to distribute the products.

Presentation of documents to registration authorities for registration of company, facility and products and taking them to aprovals.

Prepartion and maintenance of relevant data and ensuring back up.

Preparation of Dossiers and guidetrain the concerned staff of Dossiers related work and groom the team to take up higher responsibilites.(To change the relevenat point suitably like this).

Study on the existing labels, and scrutinise and approve new labels/label clims, new printed packing material.

To establish and maintain an appropriate reporting mechanism of registration information in order to maintain up to date details to the Management

Key Skills

Industry

Pharma/BioTech/Clinical Research

Functional Area

Pharma / R&D / Biotech

Number of Vacancy

10

Education

Other Bachelor Degree


About Vivimed Labs Limited

Preparation of SOPs and related documents for conducting Instrumental analysis.
Indenting the reauired lab chemicals & glassware
Conducting Analytical Methods validation and calibaration of instruments
Conducting analysis for Raw materials, In-Process and Finished products
Conducting Stability studies.
Maintenance of records as per GMP
HPLC, GC, Dissolution, UV, Polarimeter, Electronic Balance, Computers. Etc to ne operated
Use safety equipment while handling of Chemicals
In absence of colleagues he is responsible for his/her works.
Ensure the Instrument calibrations as per schedule
Ensure the column washing before starting the analysis by HPLC
Ensure the chromatographic conditions for all products at the time of analysis
Ensure the proper labeling of the reagents and buffers.
Ensure all analytical data sheets for all products, which are appeared and released by QC

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