Asst. Manager - QA (Qualification And Validation)

Asst. Manager - QA (Qualification And Validation)

1 Nos.
98478
Full Time
10.0 Year(s) To 12.0 Year(s)
9.00 LPA TO 11.00 LPA
Production / Quality / Maintenance
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; B.Tech/B.E. - Mechanical; M.Pharma - Pharmacy
Job Description:

Position:        Asst. Manager - QA (Qualification And Validation)

Location:      Sarigam Near by Vapi.

Experience:    10 to 12 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.
  • 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 - Mechanical

Salary :- 11:00 LPA

If 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 :-

Company Profile

The company is a leading pharma formulation manufacturing industry.

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