Apply for Job
Asst. Manager -QA Sterile
Posted on: 08/08/2024
Location: Bharuch
No. of Openings: 1
Qualification: B.Pharma / M.Pharm / M.Sc
Experience: 8-12 years
Salary: 12Lpa
Industry: Pharma
Job Description:
Location: Bharuch
No. of Openings: 1
Qualification: B.Pharma / M.Pharm / M.Sc
Experience: 8-12 years
Salary: 12Lpa
Industry: Pharma
Job Description:
- Responsible for Regulatory compliance for the Sterile Plant ensuring there are no major non-conformances during inspection or audits.
- Shall have capability of independently drafting SOPs of Sterile System and able to implement a Clear Quality Strategy with scalable processes and systems that enables a decision accuracy.
- Lead Investigations and work closely with stakeholders to arrive at proper root cause and corrective/ preventive measures to prevent recurrence.
- Perform In-process Quality Assurance of the Sterile Area regard to Air sampling, sample monitoring, Personnel Hygiene, Particle counts etc. to remain compliant and minimize deviations.
- Lead Media filling process validation of Aseptic manufacturing.
- Lead the Sanitization Agents / Disinfectants Qualifications in Sterile manufacturing areas.
- Responsible for WFI qualification and its validation as per regulatory requirements.
- Lead QA in the Validation and Qualification of Sterile Processes, Equipment, and Systems.
- Responsible for conducting Internal audits / Self Inspection for system enhancement.
- Should have previous experience of facing external Audits of Customers / Regulatory agencies.
- Responsible for conducting risk assessment to identify potential risks in the system/ processes and work closely with stakeholders for its mitigation plan based on the severity of the risk.