Otsuka Pharmaceuticals Recruitment for Quality Assurance ( Parenteral )

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 hrm.opmf-amd@otsukapharma.in

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: hrm.opmf-amd@otsukapharma.in
• 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 hrm.opmf-amd@otsukapharma.in