Senior QA: Validation, Compliance & Audits

Piramal Pharma Ltd; Barneveld; On-site; EUR 45,000 - 65,000; Full time

Job summary

Piramal Pharma Solutions in Barneveld, Netherlands, seeks a Senior Executive - Quality Assurance to drive equipment qualification, validation and QA activities for both sterile and non-sterile areas, ensuring compliance with ICH Q9 and site procedures.

You will coordinate cross-functional teams, manage audits and CAPA, maintain documentation, support vendor assessments, and train staff to uphold GMP standards at the site.

Responsibilities

• Preparation, execution and review of protocols for Equipment qualification, Area and HVAC qualification, Utility Qualification including temperature mapping for Non-Sterile and Sterile area as per VMP.
• Perform media fill and SIP Validation
• Risk assessment as per ICH Q9, with impact assessment of Change controls
• Preparation, execution and review of protocols for Equipment qualification and Computer system Validation, Area and HVAC qualification, Utility Qualification including temperature mapping for Non-Sterile and Sterile area as per VMP.
• Preparation of BMR /BPR as required
• Execution of CMP and CML for Validation Instruments
• Coordinate with cross-functional team and customer for timely completion of validation activities
• Coordinate with Vendor for validation/qualification activities
• IT Supplier Assessment, Periodic review, and Audit trail review
• On-Boarding, training, and Off-boarding of service staff provided by the Vendor/Supplier Organization
• Handling of Media fill related activity, SIP Validation and personnel qualification
• Handling of Audits, Internal as well as external
• Provide compliances against audit findings and corrective actions
• Handling of Track Wise related activities and ENSUR related activities (Initiation of documents)
• Handling of QMS Activities (Incident, Deviation, CAPA Investigation etc.)
• Maintaining documents as per site procedures, Archival and disposition of documents
• Support to site DICO for monitoring and implementation of actions related to Data Integrity awareness at site
• To ensure the EHS related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as per EHS requirement
• To attend training session (onsite/ offsite) and provide training to concerned personnel
• Handling/ execution of other job as per the instructions of the superiors

Job description

Piramal Pharma Solutions in Barneveld, Netherlands, seeks a Senior Executive - Quality Assurance to drive equipment qualification, validation and QA activities for both sterile and non-sterile areas, ensuring compliance with ICH Q9 and site procedures.

You will coordinate cross-functional teams, manage audits and CAPA, maintain documentation, support vendor assessments, and train staff to uphold GMP standards at the site.