Validation Expert

Sandoz; Gebze; On-site; TRY 40,000 - 60,000; Full time

Job summary

A global pharmaceutical company in Turkey is seeking a Validation Expert to maintain process control strategies and ensure compliance with GxP regulations. Ideal candidates have strong project management and collaboration skills, with a focus on process validation and continuous improvement in the pharmaceutical field. This role demands a commitment to quality and technical excellence.

Qualifications

• Experience in Fix-its/Turnarounds.
• Project Management experience.
• Collaborative skills across boundaries.
• Operations Management and Execution experience.

Responsibilities

• Support Product Steward in maintaining the process control strategy.
• Prepare and review GxP documentation including change requests.
• Contribute to lab instructions, SOPs, and templates.
• Support validation planning and activities.
• Design and document experiments for assigned products.

Skills

Assembly Language

Change Control

Chemical Engineering

Chemistry

Continual Improvement Process

Cost Reduction

Data Analytics

Electronic Components

General HSE Knowledge

Knowledge Of CAPA

Knowledge Of GMP

Lean Manufacturing

Manufacturing (Production)

Manufacturing Process

Pharmaceutics

Process and Cleaning Validation

Process Control

Process Engineering

Risk Management

Root Cause Analysis (RCA)

Six Sigma

SOP (Standard Operating Procedure)

Job description

Job Description

Major accountabilities

• Validation Expert -Support Product Steward in maintaining the process control strategy.
• Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
• Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
• Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV).
• Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation readyScientist MSAndT -Comply with applicable GxP regulations, SOPs, HSE, ISEC And other Sandoz Guidelines in the laboratory and, -Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving.
• Contribute to and maintain lab instructions, SOPs, templates.
• Support, qualification and calibration of lab / pilot equipment with accompanying documentation, schedule and perform routine maintenance.
• Contribute to the evaluation of new equipment.
• Design, execute and document experiments (formulation / analytical tests etc.) for products assigned in the context of process transfer, process improvement and process validation.
• Prepare and review appropriate GxP documentation including change requests.
• Participate in Tech Transfer activities from laboratory to industrial scale, support validation activities.
• Identify improvement options of current processes, propose business cases.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key Performance Indicators

• Meet established validation milestones according to approved validation plans.
• Audit and inspection outcomes as a measure of validation compliance with global regulatory expectations.
• Timing and quality of technical reports.
• Timely and successful implementation of transfer activities (e.g. lab-to-lab transfer in launches).

Minimum Requirements

Work Experience

• Fix-its/Turnarounds.
• Project Management.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills

• Assembly Language.
• Change Control.
• Chemical Engineering.
• Chemistry.
• Continual Improvement Process.
• Cost Reduction.
• Data Analytics.
• Electronic Components.
• General Hse Knowledge.
• Including Gdp.
• Knowledge Of Capa.
• Knowledge Of Gmp.
• Lean Manufacturing.
• Manufacturing (Production).
• Manufacturing Process.
• Pharmaceutics.
• Process and Cleaning Validation.
• Process Control.
• Process Engineering.
• Risk Management.
• Root Cause Analysis (Rca).
• Scheduler.
• Six Sigma.
• Sop (Standard Operating Procedure).

Languages

• English.