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KEY ACCOUNTABILITIES
1.Analysis and approval
Supporting in-process control sample testing by online analysis to support production activities Sampling, analysis and ascertaining quality of 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, CWH 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) 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
Maintaining LIMS data entries
Providing technical support in compiling Annual Product Review.
Analytical method development when required.
2.6.Executing on line documentation
Laboratory Management
Qualification and Validation of instruments/equipment
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 Quality control.
Laboratory equipment calibration and their maintenance.
Developing training modules for improvement / training for HSE and Quality systems
Generate up gradation plans as need basis.
Any other activity assigned by the In charge, Quality control
Quality, HSE and Compliance
Adhere to current GMP guidelines
Following ALCOA+++ practices during documentation and related activities
Compliance to local and international HSE norms
Regulatory compliance
ISO 14000 related activities
Regular Pharmacopoeia and regulatory requirement review for compliance
To participate in any regulatory/Customer inspection takes place at the site
Training of self and subordinates on quality and HSE systems
Team member
Member of validation team.
Member of Analytical transfer team.
Participating in discussions and giving feedback to Manager, Quality control regarding on-going activities.
Other projects
Trouble shooting activities.
Participation in Industrial Excellence projects.
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
Plant round in absence of QA and during IInd and IIIrd shift.
Online checking of critical process parameters during round.
REQUIREMENTS
Education / Experience
M.Sc. Analytical/Organic Chemistry/Inorganic Chemistry
Min. 2 years’ Experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment
Technical skills & Competencies / Language
- Technical competence
- Leadership skills
- Analytical ability
- Planning ability
- Communication skills
- Problem solving
- Team Building
