Quality Head – Pharma
Full time @Sahyog Jobs Consultancy posted 3 hours ago in ManufacturingJob Detail
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Career Level Manager
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Experience 8 Years +
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Industry Pharma/Biotech
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Qualifications Master’s Degree
Job Description
Quality Head – Pharma
Exciting opportunity for experienced Quality professionals to lead Quality team at our Roscommon, Ireland facility
– Ideal for candidates with 15 – 20 years of experience in pharma or medical device manufacturing seeking international leadership exposure.
ROLE:
– Point of contact to authorities as Management Representative Set direction and identify priorities regarding Compliance and Regulatory.
– Employees are expected to support the quality concepts including a variety of job-related tasks which may not be specific to this position profile.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Leadership:
– Set Quality Objectives and goals for the Quality Management System and site that are aligned to the site strategy.
– Implement and maintain the Quality Management System in line with ISOÂ requirements, and other relevant regulatory requirements and ensure that the site is audit ready at all times.
– Ensure that a monitoring system is in place to ensure our Quality Management System is kept in compliance and updated as necessary in line with regulatory changes.
– Ensure quality and regulatory personnel are competent in the activities performed as part of ISO 13485, FDA, MDR and customer requirements.
– Ensure implementation and effective management of Quality Management System elements including: Internal Audit program, Document Control, Change Management, Validation, Non-conformance management, CAPA, Deviation, Supplier Management, Risk Management, Complaint Management, Vigilance and Post Market Surveillance:.
– Lead on-site regulatory inspections as Management Representative.
– Ensure that requirements related to incoming inspection, in process inspection and product release are implemented and effectively managed.
– Ensure that product packaging, labelling and IFU requirements are understood and implemented and that artwork is kept up to date.
– Ensure that requirements for sterilization of product and environmental monitoring are implemented and effectively managed.
– Ensures that Management Review is performed as required by relevant site procedures.
– Ensures that site Quality metrics and KPI’s are developed, reviewed and evaluated.
– Leads assigned global quality projects and compliance initiatives where necessary.
– Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
– Provide leadership and development to the organization to maximize effectiveness and assist development of employees concerning the Quality Management System.
– Acts as site responsible person for Vigilance activities including reviewing of complaints for vigilance determination, initiating reporting and vigilance activities.
EXPERIENCE:
– Excellent working knowledge of Quality System Requirements such as ISO 13485 , FDA 21 CFR and the MDR regulations.
– At least 5 years’ experience in a senior leadership position.
COMPETENCIES REQUIRED:
– Experience in working in a high volume medical device production facility.
– Strong computer skills Change control management; Design Control, and process control including the use of automated management systems.
– Certification as an auditor to ISO 13845 is highly desired.
– Good customer relation skills.
– Ability to present an independent opinion.
– Quality of work / attention to detail; maintains high standards despite pressing deadlines.
– Problem Solving (using recognized tools) and decision making (makes sound factual decisions).
Interested candidates can share their CV at hrd.sahyog@gmail.com & 8860385576 (WhatsApp)