Senior Executive-QA

Piramal Pharma Ltd; Barneveld; On-site; EUR 40,000 - 60,000; Full time

Job summary

Piramal Pharma Solutions in the Netherlands is seeking a Senior Executive-QA to oversee IPQA activities such as sampling, LC, shop floor compliance and BPR review.

The role emphasizes ensuring system and procedure compliance per cGMP and ISO 13485, safeguarding data integrity, calibration of IPQA instruments, and training new employees. You will monitor in-process quality, manage line clearances during changes, and contribute to documentation and QA software usage.

Qualifications

• Experience with cGMP and ISO 13485 compliant shop floor processes.
• Strong focus on data integrity and documentation practices.
• Hands-on IPQA activities including calibration and sampling.

Responsibilities

• Ensure system and procedure compliance per cGMP and ISO 13485 in shop floor, warehouse and engineering.
• Data integrity compliance at site during activities.
• Support EHS tasks, report near misses and incidents as observed.
• Monitor product quality, in-process control and manufacturing environment.
• Perform AQL and in-process testing for manufacturing and packing.
• Approve line clearances during product changes over/batch change over.
• Sample pooled, micro, FG, stability samples with related documentation.
• Calibrate IPQA instruments.
• Train new employees on systems and procedures.
• Review and approve batch manufacturing/packaging documents.
• Online stage-wise BMR/BPR review.
• Manage alarms/audit trails and trend analysis.
• Handle material on shop floor via MRN, LRN, MRQN.
• Submit in-process analysis reports from QC to production after review.
• Handle non-conformance and line-failure activities with documentation.
• Handle QAAS, CPV, and CLEEN software.

Skills

cGMP

ISO 13485

Data integrity

IPQA

EHS

Tools

IPQA Instrument

Job description

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

Senior Executive-QA

Job Description

IPQA activities like Sampling ,LC, Shop floor Compliance/BPR review, IPQA instruments calibration etc.

Key Roles And Responsibilities

• Ensure effective implementation of system and procedure as per cGMP, ISO 13485 in shop floor, warehouse and engineering along with documentation.
• To ensure data integrity compliances at site and while performing activities.
• To ensure the EHS (Environment, Health and Safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as observed as per EHS requirement.
• Monitoring of product quality, in-process control and manufacturing environment.
• To perform AQL and in process test for manufacturing process as well as packing stage.
• Approval of line clearance during product changes over/ Batch change over.
• Sampling of Pooled samples, Micro sample, FG control samples, stability samples and other samples as per requirement along with related documentation.
• To perform calibration of IPQA instrument.
• Training of new employees, system practices and procedure to develop competency.
• Review and approval of executed batch manufacturing, packaging documents & other quality documents.
• Online stage wise BMR/BPR review.
• Responsible for alarm/audit trail review and trending of alarm as and when required.
• Handling of material on shop floor through approval for MRN, LRN, and MRQN.
• Submission of In-process analysis report from QC to production after review.
• Handling of non-conformance and Line failure activity along with related documentation.
• Handling of Ensur, SAP & trackwise activity as per Quality Assurance procedure.
• Handling of QAAS, CPV, and CLEEN software.