Job Description

Position:Asst. Manager - QA (Qualification And Validation)Location:Sarigam Near by Vapi.Experience: 10 to 12 YearsIndustries:PharmaResponsibilities:

• 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.
• Strong communication skills (written and verbal).
• 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

Required Qualification: -B. Pharm/M. Pharm/B.E/B.Tech/M.E/M.Tech - MechanicalSalary :- 11:00 LPAIf you are interested for this opening please send updated resume on same mail with following details.Total No. of Years Experience :-Current CTC :-Expected CTC :-Notice Period :-

Quality HR India