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.
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).
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