Min. 5 years’ Experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment, with exposure to method development and validation activities
Technical skills &
Competencies / Language
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Technical competence.
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Leadership skills.
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Analytical ability.
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Planning ability.
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Communication skills.
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Problem solving.
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Team building.
KEY ACCOUNTABILITIES
Analysis and approval
Sampling, analysis and ascertaining quality of raw materials, packaging material, intermediates, In-process samples and API for Chemistry Ankleshwar.
Testing of the method validation samples and process validation samples and cleaning validation.
Perform analysis and documentation of API finished product stability study as per stability study protocol.
Coordinating with Production, Stores and QA for Approval / Rejection of raw materials/finished product.
Validation and verification of analytical procedures as per requirement.
Reporting OOS / OOT results and deviations.
Maintaining retained samples as per standard procedure.
Assisting in investigation of customer complaint.
Testing of recent samples (Vendor approval)
Training of subordinates
Give required suggestion for corrective actions and to plan effective preventive actions for the up gradation of the quality system.
To ensure proper maintenance of the stability samples and their management.
Disposal of waste according to the approved procedures.
Continual reduction in the waste generation and effluent management.
Co-ordination with microbiology lab (Pharmaceuticals) for microbial analysis of products and utilities.
Documentation
Generation, managing and archiving Documents including raw data, reports, COA etc as per requirements.
Preparation and implementation of the SOPS in the laboratories system.
Specification preparation and implementing for API raw material and API finished