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