Executive, Quality Control

Job Description / Responsibility

• Capable to operational of all laboratory instruments mainly FTIR, HPLC, and ICP-OES & GC.
• Detail knowledge about analytical method validation & dossier document preparation.
• Capable to carryout stability study (LT01 & LT02)
• Sampling, Analysis & release of Raw material, Finished Product & Packing material
• Preparation, training and execution of related SOP.
• Sampling & analysis of all types of water (PW, PWG, ETP, boiler water etc.).
• Management & qualification of Reference standard & working standard.
• Detail knowledge about cleaning solution analysis for cleaning validation.
• Clear concept about GLP, GMP, GDP & other regulatory guideline for pharmaceutical
• Capable to calibration & qualification (DQ, IQ, OQ, PQ) of all QC equipment.
• Capable to audit & Visit management (External and Internal)
• Preparation, checking, review and implementation of analytical reports and other documents.
• Routine maintenance and cleaning of QC equipment.
• Any other relevant duties assigned by supervisor, execute time to time.

Basic Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry or related scientific discipline.
• Master’s degree in the relevant fields is strongly preferred.
• 3-4 years of laboratory experience in GLP & cGMP regulated environment.
• Detail-oriented, ability to work independently
• Ability to visualize and diagrammatically explain processes
• Strong interpersonal and communication skills, both written and verbal
• Strong computer proficiency
• Strong MS Word, MS Excel, MS Visio, Adobe Acrobat background
• Familiar with root cause analysis and Corrective Action / Preventive Action procedures
• Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Response well to questions; Writes clearly and informatively; Presents numerical data effectively
• Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviours and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
• Strategic Thinking – Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices.
• Computer skills: MS Office (Word, Excel, PowerPoint and Access).