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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- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.