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Post : Assistant Manager - Quality Control
Job Description
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 new 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 product according to requirement.
• Providing technical support in compiling Annual Product Review.
• Analytical method development when required.
Laboratory Management
• Qualification and Validation of instruments/equipments
• Appropriate training and guidance to the subordinates.
Safety in the laboratory.
• Regular housekeeping and upkeep of the work area.
• Maintaining adequate inventory of chemicals and reference standards.
• Adapting relevant technologies and systems in Analytics.
• Laboratory equipment calibration and their maintenance.
• Developing training modules for improvement / training for HSE and Quality systems
• Generate up gradation plans as need basis.
Regulatory and other Compliance
• Compliance to current GMP guidelines.
• Compliance to local and international HSE norms.
Regulatory compliance
• Regular Pharmacopoeia and regulatory requirement review for compliance.
• To participate in any regulatory inspection that takes place at the site.
• Training of self and subordinates on quality and HSE systems.
• Any other activity assigned by the In charge, Analytics
Team member
Member of validation team.
Participating in discussions and giving feedback to Manager, Analytics regarding on-going activities.
Other projects
• Trouble shooting activities.
• Participation in Industrial Excellence projects.
• Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations
Candidate Profile
M.Sc. Analytical / Organic Chemistry / Inorganic Chemistry Min. 5 years’ Experience in a Quality Control / Analysis laboratory in a cGMP/ISO environment, with exposure to method development and validation activities.
Additional Information
Experience : 5 years
Qualification : M.Sc
Location : Ankleshwar
Industry Type : Pharma
Functional Area : Quality Control
End Date : 25th October, 2018
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