Otsuka Pharmaceuticals is hiring For Quality Assurance ( Parenteral ).Otsuka Pharmaceutical Co., Ltd., abbreviated OPC, is a pharmaceutical company headquartered in Tokyo, Osaka and Naruto, Japan. The company was established August 10, 1964
Vacancy Details :
- Company Name: Otsuka Pharmaceuticals
- Location : Ahmedabad
- Post Name: Quality Assurance ( Parenteral )
- Qualification: B.Sc/M.Sc/B.Pharm/M.Pharm
- Experience: 01-05+years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Contact: Interested candidates can share their resumes on  hrm.opmf-amd@otsukapharma.in
- Mode of application : OnlineÂ
- Selection Process: interview
Job Description/Skills Required :
For IPQA/QMS :-
- 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.
Candidate Profile :-
- Ready to work in rotational shifts.
- Excellent understanding about working area.
- Initiator and Learner.
- Decision Making ability.
- Team player and if required, can provide training to other team members.
- Good communication.
- Exposure in Parenteral Formulation.
Interested candidates can share their resume on hrm.opmf-amd@otsukapharma.in
