AS&T Specialist

TR11 (FCRS = TR011) Sandoz Grup Sağlık Ürünleri İlaçları Sanayi ve Ticaret A.Ş.; Gebze; On-site; TRY 167,400 - 279,000; Full time

Job summary

TR11 (FCRS = TR011) Sandoz Grup Sağlık Ürünleri İlaçları Sanayi ve Ticaret A.Ş. is seeking a qualified candidate for analytical method validation and transfer activities. Responsibilities include developing and validating methods for raw materials and finished products, along with qualitative and quantitative analyses of organic and inorganic compounds.

The ideal candidate holds a degree in Pharmacy, Chemical Engineering, or Chemistry with 3-5 years of experience in a GMP environment. Strong communication and teamwork skills, along with fluency in English, are essential.

Qualifications

• Approx. 3 to 5 years in pharmaceutical industry and/or analytical laboratory in GMP environment.
• Knowledge of cGMP & cGLP.
• Fluent in English.

Responsibilities

• Execute main activities according to prepared SOPs and laboratory rules.
• Prepare analytical method development, re-validation, validation, transfer and stability protocols and reports.
• Participate in laboratory investigations.

Skills

Communication skills

Continuous learning

Decision making skills

Self-awareness

Education

University degree in Pharmacy, Chemical Engineering or Chemistry

Tools

HPLC

GC

UV/Vis

Job description

Job Description Summary

The role is responsible for analytical method validation and transfer activities. This includes the evaluation, development and validation of methods required for raw materials and finished products. Performs qualitative and quantitative analyses of organic and inorganic compounds to determine the identity, purity and homogeneity of drug substances and products related to each project. Organizes and interprets all data obtained using a wide variety of instrumental technologies.

Major Accountabilities

• Execute the main activities according to prepared SOPs and laboratory rules.
• Fulfill the responsibilities, which are given by AS&T team Lead and QC manager at the right time and correctly in conformance with methods, procedures and workflow.
• Follow the global analytical method development studies, current guidelines and pharmacopoeias.
• Prepare analytical method development, re‑validation, validation, transfer and stability protocols and reports.
• Create and revise SOPs, FRMs.
• Participate in laboratory investigations.

Minimum Requirements

• University degree in Pharmacy, Chemical Engineering or Chemistry.
• Approx. 3 to 5 years in pharmaceutical industry and/or analytical laboratory in GMP environment.
• Experience with equipment e.g. HPLC, GC, UV/Vis.
• Knowledge of cGMP & cGLP.
• Ability to work in a fast‑paced changing environment.
• Team working and costumer‑oriented mindset.
• Strong interpersonal written and verbal communication skills.
• Good knowledge of MS Office and other standard IT applications.
• Fluent in English.

Skills

• Communication skills
• Continuous learning
• Decision making skills
• Self‑awareness

Desired Skills

• Communication Skills
• Continued Learning
• Dealing With Ambiguity
• Decision Making Skills
• GXP
• Industry Standards
• Laboratory Equipment
• Laboratory Excellence
• Quality Control (QC) Testing
• Quality Control Sampling
• Self‑Awareness
• Technological Expertise
• Total Quality Management