Apprentice

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Apprentice

Job Description

JD - Apprentice QA

Area and line clearance for Manufacturing, Packing & Dispensing activity in production area.
In process checks in Manufacturing and Packing activity.
Daily verification of weighing balance calibration activity.
Daily verification of environmental monitoring of raw material staging area and Manufacturing and Packing area.
Verification of each equipment cleanliness and area cleanliness during line clearance.
Verification and review of online Batch Manufacturing and Packing Records.
Issuance of BMR / BPR, logbooks, formats to production department
Sampling of bulk stage and finished goods analysis and control sample.
Execution of Process validation, Cleaning Validation & Qualification activity.
Sampling of validation samples (Process, Packaging & cleaning), rinse & swab samples.
Verification of production documents.
In process quality checks in manufacturing dept.
Review of production records and Finished Goods verification.
On job training to the new joiner (IPQA personal) working in the production area.
Statistical Process Monitoring.
Online observation of process deviation and effective implementation of CAPA.
Reporting of daily non-conformance.
Execution of requirements for food / dietary supplements regulations for export market (US)-21 CFR Part 111.
Ensuring avoidance of breach of data integrity in area.
Implementation of effective sanitation program in area.
Imparting required training to shop floor personnel.
Adherence to the requirements of EHS norms.
Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset).
Customer / Patient centricity.
Document Archival.
To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
To implement QEHS policy & objectives.
To ensure participation and consultation of worker.
Ensure use of PPE
To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
To ensure work permit system during maintenance activities.
To implement QEHS continual improvement projects at site and monitor.
To ensure disposal of waste.
Authorised to prevent improper workplace conditions.
Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
Authorised to prepare OH&S performance document.
Authorised to conduct training of workmen’s related to OHSMS.
Review & handling of market complaint ensuring the quality and integrity of all GXP data and documentation generated.