QA Associate

Role & responsibilities

Review of the executed manufacturing documentation at contractual partners and ensure its compliance with internal Quality Management System and applicable Regulatory Guidelines in cooperation with Quality Management at Krka.

Reviewing the manufacturing documentation of pharmaceutical products and identifying potential errors or irregularities.

• Participates in investigation of deviations, complaints, unfavorable trends, and OOS results with contractual manufacturers.
• Participate in harmonization of applicable change controls.
• Takes part in organizing audits of our contractual partners in line with the audit plan and monitors its realization.
• Monitors the manufacturing/control processes at suppliers/contractors.
• Cooperates in reviewing annual Product Quality Review reports for products manufactured for Krka as per contract.

Follows Indian legislation related to production of intermediates, active ingredients and finished products, and makes a comparison with the legislation of target markets.

• Acts in accordance with guidelines and instructions from Quality Management at Krka.
• Implements legislation requirements specific for the area of work.
• Manages documentation from their area of work.
• Follows trends, implements measures and prepares periodical reports for the area of work.
• Other tasks delegated by Krka Quality Management in accordance with employee's qualifications and the needs of the working process.

Responsibilities

for correct, professional and timely performance of tasks;

for complying with legislation that applies for the manufacture of pharmaceuticals and active ingredients;

for quality and timely preparation of reports;

Knowledge required:

- General knowledge of regulatory requirements and standards in the pharmaceutical industry for EU

- Good knowledge of pharmaceutical manufacturing procedures and good manufacturing practice.

- Knowledge regarding handling of deviation, complaints and changes

- Good communication skills for effective collaboration with other team members and contract manufacturers

- Reliability and accuracy when reviewing documentation.

- Proficiency in English language

- ISO 9001 standard;