Senior Executive - Quality Assurance

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

Be the First to Apply

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 - Quality Assurance

Job Description

• 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
• To perform the Risk assessment as per ICH Q9, along with impact assessment of Change controls.
• Preparation, execution and review of protocols for Equipment qualification & 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 and when required.
• Preparation and Execution of CMP and CML for Validation Instruments.
• To coordinate with cross functional team and customer for timely completion of validation activities.
• To coordinate with Vendor (third party for validation) for timely completion of validation/qualification activities.
• To perform the IT Supplier Assessment, Periodic review, and Audit trail review.
• To carry out the 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.
• To provide compliances against audit findings and to ensure appropriate corrective actions based on audit findings.
• 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 as per site procedures, Archival and disposition of documents.
• Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
• 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 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