QA(IPQA/Validation/QMS)
Otsuka Pharmaceuticals
Full time- 2+ years
- Not Disclosed
- Ahmedabad, India
- Post Date: Apr 16, 2024
- End Date: Jun 16, 2024
- 2+ years
- Not Disclosed
- Ahmedabad, India
- Post Date:Apr 16, 2024
- End Date: Jun 16, 2024
Skills:
- bpharm
- mpharm
- Management
Job Description:
Responsibilities
- Execution of All IPQA related activities within manufacturing unit.
- Line clearance, in-process dispensing and sampling activities.
- BMR/BPR issuance, review and preparation under the guidance of seniors.
- Issuance of Standard Formats and submitting the documents.
- Preparation of SOP as per the current organization norms and cGMP guidelines under the observation of seniors.
- Execute routine IPQA monitoring.
- Review and approve on-line documentation of manufacturing, testing and packing activity.
- Investigation of any deviation / abnormal observation.
- Review the GDP issues in Production / QC / QA and in logbooks.
- Execute CAPA defined by management/QMS.
- Review critical quality attributes of products, review trend analysis and keep track of OOT results.
- Execution of All Process Validation related activities within manufacturing unit.
- Review process validation, qualification planner.
- Conduct Material issuance for validations activities.
- Sample withdrawal during process validation.
- Record observations in observation sheets for process validation.
- Coordinate and execute process validation, qualification activities & inform about deviation from planning.
- New equipment qualification & validation.
- To help in identification of any deviation and report further.
- To support in investigation of any product deviation and Out of Specification (OOS).
- To suggest / recommend the changes in the Standard Operating Procedure (SOP).
- To help in investigation of OOS and Documentation of the same.
- To be updated about the new changes in all international and local regulatory requirements.
- To monitor and implement the Good Manufacturing Practice (GMP) standards in the plant.
- To help in conducting monthly Corrective and Preventive Action (CAPA) meetings and preparation of CAPA summary report and gather CAPA details generated from individual quality sub-systems (e.g. Deviation, Change Control, OOS, Complaint, External inspection, Self-inspection)
Qualification & Experience
- B.Sc / M.Sc / B.Pharm / M.Pharm
- Experience : 02-07+years
Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years of Experience"
-
Salary
Not Disclosed
-
Role
Executive or Officer
-
Area of Practice
- Quality Assurance/ Quality Control
-
Experience
2+ years
Remove this line later