Quality Assurance Officer

Year    Mumbai, Maharashtra, India

Job Description

IGNORE IF Already Applied .Required Qualification:
1. M-Pharm or B-Pharm with Hands-on experience as QA Pharmacist in GMP / GDP environment2. Good Command over English.3. Mandatory to have Valid Pharmacy License and PPP.4. Experience : 5-10 years experience Mandatory*5. Age Limit : Up to 40 years1. Preparation, Revision & Training of QA SOP's:Hands on Experience of SOP ManagementPreparation & Revision of QA SOP's in Control Document Management System (CDM'S) as per requirement.
To conduct Training of approved QA Sop's to all concerned persons.2. Audit & Inspection Readiness:Preparation of Annual Internal Audits schedule.
Performing Internal Audits as per approved schedule.
Preparation of Internal Audits report.
Raised the CAPA's in Track-wise system after agreement with stakeholders.
Verification of CAPA's effectiveness
after predefined period.3. Periodic Product Review:Preparation of Periodic Product Review (PPR) of the products.4. Preparation of Periodic Product Review (PPR) of the products.To support contract manufacturing sites for validations during product transfer.5. Process, Equipment, Facility & Utility Qualification:To permed change control assessment validation / qualification perspectives.
Preparation and Maintenance of Site Validation Master Plan (SVMP).
Preparation of Monthly presentation on Site validation Steering Committee.
Tracking of monthly re qualification schedule.
6.Cleaning Validation:Preparation of Cleaning Validation Protocols & Reports.
Performing Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) Study.7. Quality Management Systems:To carry out the gap analysis against Quality Management Systems.Handling change controls , deviations and CAPA's.
Carry out risk assessment in view of change in process / introduction of new product.
Raise and progress departmental change controls, deviations and CAPA'sJob Type: Full-timeSalary: ?25,000.00 - ?45,000.00 per monthJadwal:

  • Day shift
Tunjangan:
  • Health insurance
  • Leave encashment
Upah Tambahan:
  • Commission pay
  • Performance bonus
  • Quarterly bonus
  • Yearly bonus
Ability to commute/relocate:
  • Prabhadevi, Mumbai - 400025, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Education:
  • Bachelor's (Preferred)
Experience:
  • total work: 1 year (Preferred)
Speak with the employer
+91 8999493178

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Job Detail

  • Job Id
    JD2852352
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Mumbai, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year