Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Responsibilities

To perform QC testing of raw materials, incoming goods, intermediates, and/or finished products under cGMP conditions for QC release or as part of stability studies.To support equipment qualification (if required).To perform and coordinate monitoring, calibration, and maintenance of laboratory equipment.To lead the preparation of technical documentations such as protocols, position papers and risks assessments.To perform write up for laboratory investigations, deviation and on time closure in line with Quality Management system procedures. (if required)To support method transfer/verification/validation for new product introduction.To perform periodic reviews for laboratory documents (e.g., SOPs, test methods) to ensure current, accurate and reflective of actual practices.To manage QC chemicals and consumables inventory stock check.To maintain the accuracy, completeness, and compliance of laboratory data.To participate in continuous improvement activities.To maintain own training records.To communicate effectively with cross-functional team and participate in problem solving activities.To guarantee the application and adherence to cGMP in their field.Be flexible to support shift work patterns (e.g., staggered shifts, weekend work) as required by business needs to ensure uninterrupted laboratory operations.Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab.Support and encourage a “Quality Culture” and company 4i values throughout QC.Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business.To work with HSE, cGMP and 5S in mind at all times.Undertake ad-hoc activities that may be required by the business.

Knowledge and Skills:

Ability to work independently with minimal supervision and adhere to critical timelines in a fast-paced environment.Effective verbal and written communication skills, with the ability to interact at all internal and external levels, including during regulatory audits.Excellent attention to detail with a rigorous approach to data recording and analysis.Excellent organisational and time-management skills, with the ability to prioritize multiple tasks effectively.Strong analytical thinking and systematic problem-solving skills.

Education and Work Experience:

Degree in ChemistryAt least 2 years Pharmaceutical industrial experience.Proficiency in implementing GMP regulations and adhering to various international standards throughout all facets of the role.Demonstrated ability to apply GMP regulations (FDA, EMA, etc.) and other international guidelines to all aspects of the work.Hands-on experience with analytical techniques such as HPLC, GC and dissolutionProven experience in writing technical documentation and conducting laboratory investigations.