Job Description

MISSION STATEMENT

The Transport Validation Specialist is responsible for defining the transport validation approach at Zentiva in accordance to pharmaceutical regulatory requirements, industry standards and business needs. The Transport Validation Specialist acts as Subject Matter Expert of the quality and regulatory requirements pertaining to transportation and logistics processes. He / She contributes to the edition and maintenance of Corporate Guidance documents defining Zentiva internal quality requirements. With the support of other functions, the Transport Validation Specialist defines and supports the execution of the validation exercise of the different transportation routes.

MAIN ACCOUNTABILITIES AND DUTIES

• Subject matter expert in transport validation ensuring that validation activities comply with regulatory requirements and pharmaceutical industry standards.
• Develop and execute validation protocols for processes and systems.
• Analyze and interpret validation data to identify trends, anomalies, and areas for improvement.
• Prepare comprehensive validation reports and documentation.
• Coordinate with cross-functional teams, including quality assurance, supply chain, production and relevant corporate functions.
• Perform risk assessments and develop mitigation strategies related to validation activities.
• Review and approve validation deliverables from vendors and third-party service providers.
• Conduct revalidation activities as needed to maintain compliance over time.
• Assessment and quality management of change controls related to the validation of transport activities.
• Quality management of deviations, complaints and events records and their related CAPAs.
• Edition of QA Agreements with Zentiva third parties and subcontractors.
• Prepare and participate in audits and inspections by regulatory agencies or clients.
• Stay updated with the latest regulatory guidelines and industry best practices.

OTHER RESPONSIBILITIES

QUALITY

• Adheres to the principles of GMP, GDP, MDR, HACCP and Cosmetics Regulations in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE

• Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.
• Health checkup for presence in production and audit execution

PHARMACOVIGILANCE

• All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations

COMPLIANCE

• The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

MANAGERIAL POSITIONS REQUIRE

• Creates, manages and evaluates the risk register and environmental aspects. Informs and trains employees and verifies their knowledge of the above.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

• University degree in Engineering, Life Sciences, or related field
• Minimum of 5 years of experience in validation or quality assurance roles
• Strong understanding of regulatory requirements (EMA, FDA, ICH, ISO, etc.)
• Familiarity with regulatory standards such as GMP and GDP
• In-depth knowledge of validation principles and practices
• Proficiency in statistical analysis and data interpretation
• Experience with validation in specific industries such as pharmaceuticals or medical devices
• Attention to detail and strong analytical skills
• Proficiency in using validation software and tools
• Knowledge of software validation practices for IT and automated systems
• Project management skills and the ability to manage multiple tasks simultaneously.
• Ability to work independently and as part of a team.
• Good organizational and time management skills.
• Problem-solving skills and the ability to troubleshoot validation issues.
• Experience writing and reviewing technical documents.
• Excellent written and verbal communication skills.
• Location: Ankleshwar, India