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QC Associate 29892

  • Job reference: 931458
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 22/07/2020

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


Job Purpose

Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.

Note: Candidate will be required to be on an on call rota and will be required every 6 weeks

Main Responsibilities of the role

Liaise with site Planning, Manufacturing and Inspection regarding manufacturing schedule to establish required QC testing.
* Liaise with Stability Product Representatives and Product Quality Leads as required.
* Perform routine sample management tasks as per procedures.
* With a high degree of technical flexibility, work across diverse areas within QC
* Plan and perform multiple, complex routine/ non-routine tasks with efficiency and accuracy.
* Report, evaluate, back-up/archive, trend and approve data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents and equipment.
* Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
* Operate and maintain GMP equipment, including responding and management of GMP alarms.
* Introduce new techniques/ Processes to the area, where appropriate.
* Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.
* LIMS data coordination of commercial and import testing lots where applicable
* LIMS lot logging for manufactured lots.
* Provide technical guidance, may contribute to regulatory filings.
* Represent the department/organization on various teams as required. Train others.
* Interact with outside resources.
* Perform general housekeeping in all sample management areas in line with 5S.
* Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
* Take initiative to identify and drive continuous improvements
* Communication skills (verbal and written) at all levels
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
b. Presentation skills
c. Escalate issues professionally and on a timely basis
* Decision Making skills
* Teamwork and Coaching others
* Negotiation and Influence skills
* Investigation skills
* Problem solving skills
a. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
i. Ensures compliance within regulatory environment
ii. Develops solutions to technical problems of moderate complexity
iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
b. Interprets generally defined practices and methods
c. Able to use statistical analysis tools to perform data trending and evaluation
* Project Management and organizational skills, including ability to follow assignments through to completion
Competencies:
* Demonstrated ability to work independently and deliver right first time results
a. Works under minimal direction
b. Work is guided by objectives of the department or assignment
i. Follows procedures
ii. Refers to technical standards, principles, theories and precedents as needed
iii. May set project timeframes and priorities based on project objectives and ongoing assignments
iv. Recognizes and escalates problems
* Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
* Auditing documentation and operation process
* Demonstrated ability to interact with regulatory agencies

Desired Experience and Background of the successful candidate

Bachelor's degree in a Science related field is required.
* 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 - 3 years of specific sample management/ stability programme experience is desirable.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

For more information on this role, call Kate O'Sullivan on +353 (0) 212063412 or email kate.osullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 931458

#pharmaceutical #pharma #multinational #QC #GMP


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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