Otsuka Pharma Ltd Job Opening For Msc/ Bsc/ M.Pharma/ B.Pharma - QA Dept

Otsuka Pharma Ltd Job Opening For Msc/ Bsc/ M.Pharma/ B.Pharma - QA Dept 

1. Post Name: Quality Assurance ( Parenteral )
2. Education: B.Sc./M.Sc./B.Pharm. /M.Pharm.
3. Experience:01 to 5 years
4. Location: Ahmedabad
5. Salary:NA
6. Openings: NA

 Job Description: Urgent opening at Otsuka Pharmaceutical India Pvt. Ltd, for Ahmedabad.

Roles and Responsibilities

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