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Senior QC Specialist

  • Job reference: 930624
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 26/03/2020

Orion Group Life Sciences have an exciting opportunity for a Senior QC Specialist for our Multinational Pharmaceutical client based in the South of Dublin area on a 12-month contract.

Job Purpose

This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to LIMS and Empower, without direct supervision, acting as a role model for other lab colleagues. The role provides technical expertise with a focus on Compliance, Continuous Improvement, a Lean Culture and Right First Time (RFT). Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Main Responsibilities of the role

  • Assist Management and staff with LIMS and Empower related issues
    * Provide direction and advice to support the LIMS and Empower computer related systems throughout the company
    * Interface routinely with staff across the company regarding global Quality procedures as well as LIMS and Empower related questions
    * Interface with internal customers in Product Development, Quality, Manufacturing, Analytical Sciences, etc.
    * Ensure compliance with Client requirements and GMP quality standards
    * Provide support to Chemistry and Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company's manufacturing facility and products
    * Support compliance and Quality Systems: audits, vendor qualification, change control, deviation and investigation management, corrective and preventative action systems, in-process, release and stability testing
    * Complete training on an ongoing basis as well as maintain complete training records
    * Potential to manage Quality contractors and consultants to enable initiation and maintenance of LIMS and Empower
    * Draft, review, provide oversight where appropriate to content, and approver controlled documents which may include but is not limited to product specifications, standard operating procedures, validation documents, quality policies, etc.
    * Provide input in the establishment and implementation of new LIMS and Chromatography systems along with validation philosophies and strategies for future global growth

Desired Experience and Background of the successful candidate

- Experience (5 years) in a similar role (Quality Systems, computer related systems, and biotechnology in a regulated biotechnology, pharmaceutical)

- degree qualified

- Previous LIMS and/or Empower experience (thermo LIMs experience preferred but not essential)

Both LIMS AND Empower experience is preferred.

- Appropriate GXP training.

- Knowledge of FDA and MHRA guidelines regarding GMPs (Candidate need to have worked in a GMP environment)

- Excellent verbal and written communication skills

- Keen interest is troubleshooting lab system issues and Continuous Improvement

For more information on this role, call Kate O' Sullivan on +353 (0) 212063412 or email for a completely confidential chat about this role and other opportunities using the reference number: 930624

#pharmaceutical #pharma #multinational #product #NPI #QC #qualitycontrol #LIMS #cGMP

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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