FIZA HEALTHCARE PRIVATE LIMITED
Location
Mumbai | India
Job description
Position: QA Manager
Location: Andheri East, Mumbai
CTC up to 8 Lakhs
Exp- 3-7 years
1. Quality Management/Continuous Improvement:
a. Management of Supplier Quality Assurance
b. Management of Events & CAPA
c. Management of product technical complaints
d. Investigation of Deviations and Complaints
e. Implementation of Zentiva corporate policies, Management and Control of Documents, such as SOPs, Master Documents, etc.
f. Handling of change control system
g. Preparing & review the Annual Product Quality Review
h. Batch Reworking/Reprocessing/Reincorporation (Coordination from QA point of view)
i. Review of Master Batch Manufacturing & Packing Records
j. Coordination of cGMP training activity including training of the people
k. Handling of recalls and returned goods (Coordination from a QA point of view)
l. Release and rejection of Finished Products
2. Compliance:
a. Ensure adherence to company Quality Standards, Local FDA, and other regulatory authorities
· Understanding the requirements
· ii. Performing the Gap analysis to find out the gaps in the existing system
· iii. Preparing a compliance plan for the closure of gaps
· iv. Execution of compliance plans
· v. Review of completion for compliance activity
b. Review of the regulatory dossiers, as and when required
3. Validations & Qualifications:
a. Preparation & and review of the Validation Master Plan
b. Ensure validated status of all equipment manufacturing processes, and cleaning processes
c. Review of validation plans for facility/utilities/equipment/instrument/process/computer/cleaning
d. Review of protocols for qualification and validation of facility/equipment/product/process
e. Review and certification of validation reports after execution of validation of facility /equipment/product/process
4. Documentation Control:
a. Preparation of quality system SOPs
b. Controlled distribution and archival of documents and record
c. Control of master documents
d. Management of archival room
5. Assuring quality of products by:
a. Ensuring SOP compliance
b. Controlling the changes made to facility/equipment/product/process and master documents by following the change control procedure
c. Review of Executed Batch Manufacturing & Packing Records
d. Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
e. Ensuring the effectiveness review of the implemented CAPA
f. Review of batch records and analytical testing records
6. cGMP Training:
a. To develop training modules and organize training in GMP
b. Develop and execute the overall training program in coordination with all concerned departments
7. Other:
a. Preparation and review of site master file
b. Coordinating with various agencies for making of technical agreements
c. Implementing the pest control program at the Pharmaceutical facility
d. Review of maintenance and calibration program
8. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
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