Validation Executive null

Job Description:

• Responsible as part of team of QA professionals for execution of qualification and validation activities as per Validation Master Plan in accordance to regulatory requirements.
• To co-ordinate with Engineering , Production, Warehouse and QC department for the execution of equipment, facilities and utilities qualification activities as per Validation Master Plan.
• To prepare qualification protocol and perform equipment, facilities and utilities qualification activities as per VMP.
• Ensure proper and complete validation/ qualification documents are safe keeping according to GMP requirements.
• Participate in external/regulatory audit (i.e. NPRA, ISO) and follow up the corrective action and preventive action (CAPA) needs.
• To ensure GMP practices are strictly adhered to at all time.
• Other duties as assigned by QA supervisor

Qualification:

• Degree or Diploma in Pharmaceutical Manufacturing Engineering Technology/Chemistry/Biotechnology/Engineering or whichever relevant.
• At least 1-2 working experience in pharmaceutical or biotech industry/engineering QA.

Technical/ Functional Skills:

• Proven experience in commissioning, qualification and validation of equipment (autoclave), HVAC, WFI and cleanrooms
• Cold rooms and clean utilities (sterile manufacturing) background is preferred.
• Familiarization of function and activities for quality control, production and warehouse. 
• Working knowledge and application on cGMP/GDPs/GLPs
• Proficient in MS Office application
• Experience in process validation, cleaning validation and analytical method validation will be an advantage. 

Behavioral / Management / Other Skills:

• Knowledge of validation methodologies, tools and processes
• Experience on protocol writing and reports 
• Hands-on experience with Calibrations and Preventive Maintenance activities
• Fast learner
• Able to work in a team
• Independent
• Good communications