QA Specialist - 11 Month Contract with potential extension- Hybrid
The position is responsible for activities including those listed below, alongside any other tasks as required by the business.
- Core ResponsibilitiesEnsure data integrity principles-Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA)-are adhered to for records and data in day-to-day business activities.
- Attend and successfully complete applicable cGMP training.
- Respond to operational and business areas while driving compliance with cGMP and corporate regulations.
- Drive cGMP/GDP compliance in the performance of day-to-day business activities.
- Escalate any potential violation of cGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products, and aid in their resolution.
- Liaise with Quality/Business Area Specialists, QPs, and QA Leads to resolve quality-related queries where required.
- Provide expertise and quality support for the introduction of new products onto the site in relation to product release where required.
- Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
- Report on and assist with monitoring the Quality Management Systems, generating reports for performance metrics and significant quality events or issues.
- Review and approve all manufacturing batch/material documentation, including electronic batch records, real-time reports, and master data using site systems where required.
- Identify, influence, and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
- EducationBachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
- Relevant industry qualifications or certifications in Quality Management Systems, Compliance, Auditing, or Operational Excellence are desirable.
- ExperienceTypically 3 to 5 years' experience in a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
- Demonstrated experience working within Quality Systems and Compliance functions, including management of quality records, deviations, CAPAs, change controls, investigations, complaints, and document management systems.
- Knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
- Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations.
- Skills and CompetenciesStrong understanding of Quality Management Systems and GMP compliance requirements.
- Excellent analytical and problem-solving skills with the ability to evaluate complex quality issues and identify sustainable solutions.
- Strong written and verbal communication skills, including technical writing and report preparation.
- Ability to manage multiple priorities and deliver results within agreed timelines.
- Effective stakeholder management skills with the ability to influence across functions and levels of the organization.
- Strong attention to detail and a commitment to maintaining data integrity and quality standards.
- Ability to interpret regulatory requirements and translate them into practical site procedures and processes.
- Proficiency in Microsoft Office applications and electronic quality management systems.
- Demonstrated capability to drive continuous improvement and support a culture of quality and compliance.
- Preferred ExperienceExperience with site Quality Systems governance, metrics, compliance monitoring, and inspection readiness activities.
