Quality Assurance ( IPQA / Validation / 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.
• 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.
• To help in identification of any deviation and report further.
• To support in investigation of any product deviation and Out of Specification (OOS).
• To suggest / recommend the changes in the Standard Operating Procedure (SOP).
• To help in investigation of OOS and Documentation of the same.
• To be updated about the new changes in all international and local regulatory requirements.
• To monitor and implement the Good Manufacturing Practice (GMP) standards in the plant.
• To help in conducting monthly Corrective and Preventive Action (CAPA) meetings and preparation of CAPA summary report and gather CAPA details generated from individual quality sub-systems (e.g. Deviation, Change Control, OOS, Complaint, External inspection, Self-inspection).

Walk in on 18th December, 2021

Time:- 9.30 AM - 3.00 PM

Venue:- Otsuka Pharmaceutical India Pvt Ltd 21st Floor, B-Block, Westgate, Nr. YMCA, S.G Highway, Ahmedabad - 380 015

Candidate who cannot appear walk interview they can send their CV on given MailId.