Executive - Quality Control, Pharma

Requirements

• Education / Experience
• POST GRADUATE IN CHEMISTRY/PHARMACY
• Experience: 3-5 years in a Quality Control/Analysis laboratory in a cGMP/ISO environment, with exposure to method development and validation activities
• Technical skills &
• Competencies / Language
• Technical competence
• Leadership skills
• Analytical ability
• Planning ability
• Communication skills
• Problem solving
• Team Building
• KEY ACCOUNTABILITIES
• 1.Analysis and approval
• 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.
• Executing on line documentation
• Statutory documentation and management
• QMS activities
• Laboratory Management Qualification and Validation of instruments/equipment's
• 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.
• 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.
• Participating in discussions and giving feedback to Manager, Quality control regarding on-going activities.
• Other projects Supporting new projects (analytical method development (need base), validation, verification)
• Laboratory compliance by reviewing documents for completeness
• Preventive maintenance, Instrument calibration
• New Instrument Qualification
• Coordination with OEMs/Service providers for timely services

Additional Information

JOB TITLE Executive- Quality Control, Pharma JOB PURPOSE Generic To perform QC activities in order to ensure quality of products and services and maintain related documentation to adhere to quality operations and regulatory requirements. All above activity shall be done living Group's Values and Code of Ethics.

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Company Intel

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