Zentiva QC Chemistry Executive Job Opening – Apply Online

Location: India / Ankleshwar

Time type: Full time

Posted on: Posted Yesterday

Time left to apply: End Date: October 30, 2024 (30+ days left to apply)

Job requisition id: R2467088

Key Accountabilities

• 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 method validation samples, 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 products.
  • Validation and verification of analytical procedures as per requirement.
  • Reporting OOS / OOT results and deviations.
  • Maintaining retained samples as per standard procedure.
  • Assisting in the investigation of customer complaints.
  • Testing of new samples (Vendor approval).
  • Provide required suggestions for corrective actions and plan effective preventive actions for the upgradation of the quality system.
  • Ensure proper maintenance of the stability samples and their management.
  • Disposal of waste according to approved procedures.
  • Continual reduction in waste generation and effluent management.
  • Coordination with microbiology lab (Pharmaceuticals) for microbial analysis of products and utilities.
• Documentation
  • Generation, management, and archiving of documents including raw data, reports, COA, etc., as per requirements.
  • Preparation and implementation of the SOPs in the laboratories system.
  • Specification preparation and implementation 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 online documentation.
• Laboratory Management
  • Qualification and validation of instruments/equipment.
  • Providing appropriate training and guidance to subordinates.
  • Ensuring 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 maintenance.
  • Generating upgradation plans as needed.
  • Undertaking any other activity assigned by the In-charge, Quality Control.
• Quality, HSE and Compliance
  • Adhering to current GMP guidelines.
  • Following ALCOA+++ practices during documentation and related activities.
  • Compliance with local and international HSE norms.
  • Regulatory compliance.
  • Participating in ISO 14000 related activities.
  • Regularly reviewing pharmacopoeia and regulatory requirements for compliance.
  • Participating in any regulatory/customer inspection at the site.
  • Training self and subordinates on quality and HSE systems.
• Team Member
  • Member of the validation team.
  • Participating in discussions and providing feedback to the Manager, Quality Control regarding ongoing activities.
• Other Projects
  • Troubleshooting activities.
  • Identifying and correcting unsafe conditions or behaviors, and promptly reporting other potentially hazardous situations.
  • Conducting plant rounds in the absence of QA and during IInd and IIIrd shifts.
  • Online checking of critical process parameters during rounds.

Education / Experience

• M.Sc. in Organic Chemistry.
• Minimum 1 year of experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment.

Technical Skills & Competencies

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

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