Position: Executive/ Sr. Executive - QA (Qualification And Validation)
Location: Sarigam Near by Vapi.
Experience: 8 to 10 Years
Industries: Pharma
Responsibilities:
Led the qualification and validation of HVAC systems to ensure compliance with regulatory standards and maintain optimal environmental conditions for pharmaceutical manufacturing.
Monitor the qualification process for water systems (e.g., purified water, WFI).
Conducted performance testing, system validation, and routine monitoring to ensure the water quality meets pharmacopeial standards.
Handling qualification and requalification activity compressed air system.
To execute equipment Qualification and requalification activity.
To execute Periodic verification of tracker machine Software e.g. checking Privileges, Desktop policy, Reconciliation, Electronic data backup, Audit trail report. (CSV).
To execute Equipment Software Validation and HMI validation.
Preparation and review of Process validation Protocol and Report.
Preparation and review of cleaning validation Protocol and Report.
Knowledge of Deviation, Change Control, OOS, OOT.
Proficient in negotiation and liaison skills.
Ability to deal with emergency situations.
Required Skills :
Must possess sound knowledge of industry by ensuring that all systems, equipment, processes and documentation.
planning and organizing Skills.
Regulatory Audit exposure of USFDA, MHRA, TGA & GMP.
Sound knowledge of MS office suit.
Ability takes decisions accordingly.
Leadership and conflict management
Organizing skills
Excellent communication skills