QA Batch Release Specialist (Worthing, Sussex)
- Employer
- Proclinical Staffing
- Location
- England, West Sussex, Worthing
- Salary
- Highly Competitive Salary
- Start date
- 28 Sep 2022
- Closing date
- 12 Oct 2022
View more
- Discipline
- Quality, QA / QC, R & D , Scientific
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Proclinical is seeking a QA Batch Release Specialist for a multinational pharmaceutical company located in West Sussex, England. The QA Specialist will review and release batches to supply fully compliant material with delivery of customer service whilst maintaining quality and safety standards for the area of their responsibility.
Job Responsibilities:
- Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
- Review and verdict documents from production areas for bulk and intermediate product release while maintaining an efficient service in line with customer demands for the release of manufactured batches.
- Give advice and assistance across site on a range of GMP topics. May be expected to carry out GMP or corrective training.
- Review and approve documents as the Quality representative such as SOPs and technical reports.
- Support validation document review and understand the impacts of change control in the area.
- Play an active part in deviation management of all types of Quality SAP notifications and reduction programs by being active in the deviation coordination and investigation process. Will provide Quality approval in accordance with site deviation management procedures.
- Expected to represent QA at the Value Stream accountability and compliance meetings and to support all performance management activities with agreed timelines and metric requirements
- Plan and prioritise work of self and colleagues when directed to do so by the area Manager.
- Use GPS process tools such as GEMBA/Process Confirmation/5S techniques to review and identify weaknesses and recommend improvements within Quality and Orals Manufacturing and Packaging processes.
- Understand the company QMS and its application to Worthing processes.
- Understanding of the regulatory requirements for the area they support.
- Adhere to the requirements of the COMPANY Values and Expectations.
Skills and Requirements:
- Preferred qualifications include a basic degree, supplemented by substantial on-the-job or job-related experience. Area of Specialisation Chemistry/Biology/Mathematics or equivalent.
- Working knowledge of cGMP, across aligned manufacturing and/or packaging areas.
- The ability to work in and lead cross functional teams.
- Flexible working as determined by the Business needs.
- Good organisation and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
- Excellent communications and interpersonal skills at all levels both written and verbal. Good computer skills.
- Understanding and ability to demonstrate use of continuous improvement techniques.
- Knowledge of deviation management and regulatory requirements.
- Knowledge and understanding of laboratory testing including out of specification investigations.
- Adheres to all applicable COMPANY personnel policies
If you are having difficulty in applying or if you have any questions, please contact Mohammed Alli at +41 61 568 79 85 or m.alli@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-MA2
#Quality
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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