Post: Executive /Sr. Officer - Quality Assurance (formulation)
No. of Posts: 05
Job Description:
1. To assist Manager QA in vendor audits, evaluation and approval of new/existing vendors & to maintain record of the same.
2. To assist Manager QA in reviewing of various documents such as deviations, change control etc. Monitoring of Deviations/Change Control, Trend preparations, tracking & follow up.
3. To identify the need for any QA related SOP, prepare the same and submit to Manager QA for approval. Established procedure for change control, training as per current international regulatory standards like MHRA, WHO etc.
4. To assist Manager QA to carryout self-inspection & to monitor overall documentation of Internal auditing Process.
5. To execute Technical Training & evaluation and trained employees on various GMP related topics such as Basic GMP, Deviations, Change Control, Market Complaint, OOS Handling, Handling of Market Complaint, Training etc.
6. To review all the production and testing related documents and submit to Manager QA for approval.
7. To carry out routine inspection of all departments for GMP Compliances.
8. To assist Manager QA in investigation of any market complaint.
9. HVAC Qualification/Validation, Equipment Qualification.
10. Preparation and review of Process / Cleaning Validation Protocols & reports.
11. To prepare annual product quality review and submit it to Manager QA for approval.
12. Validation of Computerized System i.e. SAP and its implementation
1. To assist Manager QA in vendor audits, evaluation and approval of new/existing vendors & to maintain record of the same.
2. To assist Manager QA in reviewing of various documents such as deviations, change control etc. Monitoring of Deviations/Change Control, Trend preparations, tracking & follow up.
3. To identify the need for any QA related SOP, prepare the same and submit to Manager QA for approval. Established procedure for change control, training as per current international regulatory standards like MHRA, WHO etc.
4. To assist Manager QA to carryout self-inspection & to monitor overall documentation of Internal auditing Process.
5. To execute Technical Training & evaluation and trained employees on various GMP related topics such as Basic GMP, Deviations, Change Control, Market Complaint, OOS Handling, Handling of Market Complaint, Training etc.
6. To review all the production and testing related documents and submit to Manager QA for approval.
7. To carry out routine inspection of all departments for GMP Compliances.
8. To assist Manager QA in investigation of any market complaint.
9. HVAC Qualification/Validation, Equipment Qualification.
10. Preparation and review of Process / Cleaning Validation Protocols & reports.
11. To prepare annual product quality review and submit it to Manager QA for approval.
12. Validation of Computerized System i.e. SAP and its implementation
Candidate Profile:
We are looking for appropriately qualified candidates with 3 to 5 years of relevant in Quality Assurance with a regulated Pharma company should have exposure in all sophisticated Quality Assurance.
We are looking for appropriately qualified candidates with 3 to 5 years of relevant in Quality Assurance with a regulated Pharma company should have exposure in all sophisticated Quality Assurance.
Additional Information:
Experience: 3-5 Years
Location: Mahad
Education: B.Pharma, B.Sc, M.Sc, M.Pharma
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality Assurance
Salary: 3 lacs
End Date: 1st May 2016
Experience: 3-5 Years
Location: Mahad
Education: B.Pharma, B.Sc, M.Sc, M.Pharma
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality Assurance
Salary: 3 lacs
End Date: 1st May 2016
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