Otsuka Pharmaceutical India Private Limited is hiring in QA.Otsuka Pharmaceutical India Private Limited is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan, India, for Infusion Business in India and Emerging Markets.. Interested and eligible candidates can share resume at firstname.lastname@example.org
Vacancy Details :
- Company Name: Otsuka Pharmaceutical India Private Limited
- Location : Ahmedabad( Moraiya ), Gujarat
- Post Name: Quality Assurance ( Parenteral )
- Department: QA
- Qualification: M.Sc / B.Sc / B.pharma/M.pharma/Diploma
- Experience: 1 – 5 years
- No of Vacancies: Details not provide by recruiter
- Details of Salary: Details not provide by recruiter
- Contact: email@example.com
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
For IPQA :-
- 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.
- To review Preventive Maintenance, Breakdown maintenance and perform risk assessment, suggest immediate corrective actions, report conclusion of the same.
- To maintain stability general quarantine area/ record and issue stability batch samples in case of any requirement received.
For QA-Process Validation :-
- 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.
How to Apply: share resume at firstname.lastname@example.org