Junior Manager-PSV Quality

Apotex

0 - 5 years

5 - 9 Lacs

bengaluru

Posted:1 hour ago| Platform:

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Skills Required

ehs manager quality assurance sap production support pharma risk assessment pharmacy licensing environmental monitoring api manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preparation, review and reporting of process and cleaning validation studies, APQRs & trending. Review of equipment/ support system qualifactions, calibrations and production support activities.

Job Responsibilities

Validation studies.
Preparation of Annual quality product review & Cleaning verification periodic review ..
Review of the excuted BPCRs /GCRs and Manufactiring related documentation support.
Supporting and co-ordinating for dispatch activities.
To perform the SAP related activities.
To perform viable sampling for environmental monitoring activities.
Preparation of trending reports for key starting materilas, intermediates and finished products.
Performing daily production activities like plant rounds, equipment visual cleaning clearance & RMDC release.
Preparation and revision of the Departmental SOPs, Forms and exhibits.
Monitoring of the cGMP compliance through Plant rounds.
Documentation & issuance activities.
To perform unannounced audits.
To review and take retained sample area temperature printouts.
Review of alarm summary and audit trail report in data logging system (PiSCADA).
Handling eResidue pro application.
Preparatoin of quality risk assessment reports and other related activities.
Preparation of validation master plan and exhibits.
Handling of QMS activities in trackwise (change control).
Review of equipment/ support system qualification documents.
Review of calibration certificate and monitoring of preventive maintanace activities.
Preparation of Quality trending documents for OM water, environmental monitoring and nitrogen trending etc.
To co-ordinate with the manufacturing team to address any Quality issues arises during manufacturing.
To adhere the EHS policy & procedure in routine activities.
To involve in EHS related activities on need basis.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.

Job Requirements

Education
- Minimum Masters Degree in Science /Pharmacy
Knowledge, Skills and Abilities
- Knowledge of Relevant procedure and applicable regulatory guidelins.
- Knowledge of cGMP activities.
- Knowledge on API Manufacturing activity.
- Knowledge on relavent applications.
Experience:
- 9.0 years of experience in Quality Assurance & Compliance functions.

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