Officer - Sr. Officer - Executive - IPQA

Role & responsibilities :

• In process activity in production and packing area.
• Collection of samples for Qualification batches/Routine batches/Hold time study at all applicable stages, as per defined instruction of SOP/protocol.
• Perform the Swab sampling and collection of Swab sample as per defined instruction of SOP/protocol.
• Perform Acceptance Quality Level at various applicable stages.
• Collection of Control samples and stability sample as per defined instruction of SOP/protocol and monitoring of Control sample room.
• Perform Line clearances activities as per defined instruction in SOP
• Continuous monitoring of GMP and cGMP compliance at shop floor
• Preparation, issuance and retrieval of master, control & uncontrolled documents
• Perform calibration of IPQA instrument on time.
• Preparation of MFR and review the MBR in MES
• Preparation and review of SOPs, Specification & Standard Analytical Procedures (SAPs)
• Preparation and review of various protocol & reports related to Equipment Qualification, Process validation, Hold Time, Miscellaneous & Cleaning Validation activities etc.
• To review & involved in the qualification of utility & equipment along with their software in timely manner.
• Issuance, review and control the change management activities i.e. implementation, post implementation review and proof verification.
• Participate and review the investigation w.r.t. Deviation, Market Complaint and implementation of CAPA at site.
• To prepare and review Quality risk management (QRM), APQR and Quality Trends based on requirements.
• Ensure continuous review and updation of existing procedures and systems to comply with current regulatory guidances, cGMPs and USV company policies.
• To assist in review of Pharmacopeia / Regulatory updation and implementation at site.
• To ensure the compliance of Data Integrity Governance.
• Ensure implementation of USV Quality initiatives time to time.
• To management & control of all documents at site.

Preferred candidate profile : B Pharm / M Pharm with 2 - 7 Years of IPQA Experience in OSD Manufacturing Facility