QP Dublin - Top Biotech

Dublin City Centre

Posted 25 days ago

Work Type

Permanent

Salary/Rate

€ 100,000-125,000 per annum

Remote Work

No

IR35 Status

Not Applicable

Job Title: QP Dublin
Location: Ireland
Salary/Rate: Competitive
Start Date: 1st June 2024
Job Type: Permanent


Company Introduction


A leading biotechnology company headquartered in India. One of the most prominent players in the global biopharmaceutical industry. The company primarily focuses on the development, manufacturing, and marketing of innovative biopharmaceuticals, including biosimilars, generic formulations, and novel biologics. Areas of expertise include diabetes, oncology, immunology, and other chronic diseases.


Job Responsibilities/Objectives:


· Own, review and approve SOPs and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
· Perform review and approval of validation documentation.
· Lead and participate in internal and external audits as needed.
· Maintain a close contact and familiarity with IOC & SOL Group Quality systems and programs utilised at other SOL Group sites.
· Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regard to compliance with quality policies, standards and procedures.
· Evaluates and assess change control records, non-conformances and CAPAs.
· Participate in global Quality initiatives as a site subject matter expert.
· Participate or lead projects and improvement efforts including product launches.
· Support the evaluation of quality and distribution complaints.
· Support regulatory inspections or various questions from regulatory bodies.
· Perform activities as required per IOC procedures as QA staff, and in particular where the role of QP is specified in the procedures.
· Certify in a register or equivalent document, that each production batch has been manufactured and checked in compliance with laws in force in Ireland, is in accordance with the requirements of the marketing authorization and with EU Good Manufacturing Practice (GMP).
· Ensure batches of medicinal products are distributed as per the Manufacturing Importation Authorisation and EU Good distribution Practice (GDP) as per Directive 2001/83/EC and guidance 2013/C 343/01.
· Investigational Medicinal Products QP (Directive 91/356/EEC and Directive 2001/20/EC).


Required Skills/Experience:

· Basic Qualifications for QA: University degree in a scientific or engineering area.
· Potential for progression as a QP will require a University Degree in Pharmacy OR University Degree in a Science related discipline together with a post graduate course, satisfies the educational requirements as defined in Directive 2001/83/EC.
· Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation.
· Knowledge of applicable regulatory requirements
· Relevant experience working in the pharmaceutical or Biotechnology Industry over a minimum of 2 years.


If you are interested in this opportunity, please apply below using the link or contacting Kush Obhrai at Square One,


Disclaimer
Notwithstanding any guidelines given to level of experience sought, we will consider candidates from outside this range if they can demonstrate the necessary competencies.

Square One is acting as both an employment agency and an employment business, and is an equal opportunities recruitment business. Square One embraces diversity and will treat everyone equally. Please see our website for our full diversity statement.

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