Quality Engineer

About The Company:

KKR Consulting partners with businesses to solve challenges, streamline processes, and achieve lasting success. We specialize in providing tailored consulting services across Aerospace, Medical Devices, Automotives, Pharmaceuticals, and Biotechnology industries, helping clients drive innovation, enhance operations, and achieve sustainable growth.

Job Description:

Are you passionate about driving quality excellence in life-saving products? We're looking for a Quality Engineer with solid experience in the pharmaceutical sector to join our team and ensure compliance, robustness, and continual improvement across all quality systems.

Responsibilities:

Lead CAPA investigations, root cause analysis, and risk assessments for product and process non-conformances.

Manage and improve Quality Management Systems (QMS) in line with cGMP, ICH, FDA (21 CFR Part 210/211), and EU GMP guidelines.

Review and approve validation protocols (IQ/OQ/PQ), change controls, and manufacturing documentation.

Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing) to ensure quality is integrated across the product lifecycle.

Participate in internal audits and support external regulatory inspections (FDA, EMA, WHO, etc.).

Monitor quality KPIs, lead continuous improvement initiatives, and implement lean quality practices.

Support supplier qualification and material quality assurance.

Qualifications:

Bachelor's degree in Pharmacy, Life Sciences, or Engineering (Master’s preferred).

5–8 years of experience in Quality Assurance / Quality Engineering in a GMP-compliant pharmaceutical environment.

Strong knowledge of regulatory requirements (FDA, ICH, EU GMP, ISO 13485/9001).

Hands-on experience with QMS software, deviation management tools, and document control systems.

Detail-oriented, with excellent analytical, documentation, and communication skills.