Otsuka Pharmaceuticals Hiring B.Sc, M.Sc, B.Pharm, M.Pharm for QA ( Parenteral )
Otsuka Pharmaceuticals Ltd Recruitment 2021.Otsuka Pharmaceuticals Ltd
Notification full detailes below. Otsuka Pharmaceutical India Private Limited
(OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and
Mitsui & Co. Ltd., Japan, India, for Infusion Business in India and
Emerging Markets.
Important Vacancy details:Interested candidates can share their resumes
on hrm.opmf-amd@otsukapharma.in
A. Post Name: Quality Assurance ( Parenteral )
B. Education: B.Sc./M.Sc./B.Pharm. /M.Pharm.
C. Experience:01 to 5 years
D. Location: Ahmedabad
Job Description:Urgent opening at Otsuka Pharmaceutical India Pvt. Ltd,
for Ahmedabad.
Roles and Responsibilities
For IPQA/QMS :-
BMR/BPR issuance, review and
preparation under the guidance of seniors.
Line clearance, in-process
dispensing and sampling activities. Execution of All IPQA related activities
within manufacturing unit.
Preparation of SOP as per the
current organization norms and cGMP guidelines under the observation of
seniors. Issuance of Standard Formats and submitting the documents.
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.
Coordinate and execute process
validation, qualification activities Record observations in observation sheets
for process validation. & 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
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