Traniee / Chemist / Officer - Quality Control

JobItUs; Vapi; On-site; INR 900,000 - 1,300,000; Full time

Job summary

JobItUs in Gujarat seeks a senior QC/Analytical professional with an MSc in Chemistry and 5+ years in a cGMP/ISO lab to lead quality analysis, method development and validation activities. You will coordinate with production, QA, and stores to approve or reject materials, document results, and drive continual quality improvements.

The role involves sampling, analytics for raw materials to API, stability testing, and training subordinates, with emphasis on regulatory compliance and waste

Qualifications

• M.Sc. in Analytical/Organic/Inorganic Chemistry.
• Minimum 5 years in QC/Analytical lab in a cGMP/ISO environment.
• Exposure to method development and validation activities.
• Strong analytical, documentation, and quality system knowledge.
• Leadership and training abilities.
• Effective communication and problem solving.
• Team collaboration and planning skills.

Responsibilities

• 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.
• 2.6.Executing on line documentation
• 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.
• Any other activity assigned by the In charge, Analytics
• Regulatory and other Compliance: Compliance to current GMP guidelines.
• 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 inspection that 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, Analytics 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: Plant round in absence of QA and during II and IIIrd shift.
• Online checking of critical process parameters during round.

Skills

Analytical ability

Leadership

Planning ability

Communication skills

Problem solving

Team building

Technical competence

Education

M.Sc. in Analytical/Organic/Inorganic Chemistry

5+ years in QC/Analytical in cGMP/ISO environment

Job description

Internal Job Description

Education / Experience

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

Technical skills & Competencies / Language

• Technical competence.
• Leadership skills.
• Analytical ability.
• Planning ability.
• Communication skills.
• Problem solving.
• 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 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.

2.6.Executing on line documentation

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.

Any other activity assigned by the In charge, Analytics

Regulatory and other Compliance

Compliance to current GMP guidelines.

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 inspection that 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, Analytics 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

Plant round in absence of QA and during II and IIIrd shift.

Online checking of critical process parameters during round.