Quality Specialist

2 weeks ago

Basildon Essex, United Kingdom Lifelancer Ltd Full time

3 weeks ago Be among the first 25 applicants

About the role:

Reporting to the Qualified Person (QP), you will be a key member of the team which is responsible for providing a quality support to the Quality Systems, Operational Quality and Technical Quality teams.

About the role:

Reporting to the Qualified Person (QP), you will be a key member of the team which is responsible for providing a quality support to the Quality Systems, Operational Quality and Technical Quality teams.

Our Quality Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities duties:

  • Perform distributor Audits and progress QTAs with distributors
  • Provide Quality Operations support to approved vendors and ensure that any risks are communicated effectively
  • Review pharmaceutical product batch files for timely release by Responsible Person (RP), Responsible Person for Importation (RPi), or certification by Qualified Person (QP)
  • Provide QA support to the business during root cause analysis investigation
  • Raise on request or using own initiative Third party notification, CAPA, GDP issues, Deviation and Change Control
  • Support activities required to effectively maintain the company Pharmaceutical Quality System
  • Monitor alerts for potential overdue for Complaints, CAPA, GDP issues, Deviation and Change Control
  • Compliant review of batch documents in preparation for QP RPi, or RP release
  • Completion of assigned Quality and Technical Agreements to eliminate any overdue
  • Track and follow up on all outstanding assigned Quality and Technical Agreements
  • Participate in internal and external audits
  • Participate in reviews of OOS and RCAs in a timely manner, with timely escalations to HOQ/QP as required
  • Work with relevant stakeholders to achieve timely completion of all CAPAs relating to Customer and Internal Audit audits
  • Ad hoc quality support, communication of risks, and other tasks as assigned

About you:

  • Candidates with proven relevant experience gained within a pharmaceutical quality department are likely to have the skills required to be successful in this role. We are also looking for:
  • Bachelors degree in Pharmaceutical Science or equivalent
  • Postgraduate degree or diploma is desirable
  • Great IT skills including MS software/programs
  • Experience gained in manufacturing, API, solid dosage forms, liquids, creams and sterile products
  • Experience of facilitating OOS and Root Cause Analysis
  • Routine preparation of Quality and Technical Agreements
  • Good working knowledge of current GMP, SOPs, EU GMDP and ICH guidelines and regulations
  • Previous auditing experience would be an advantage
  • Excellent time management and organisational skills with demonstrated ability to juggle multiple competing tasks and demands
  • Ability to work successfully within cross-functional teams as well as independently
  • Excellent professional communication skills, both written and verbal

Please use the below link for job application and quicker response.

Seniority level
  • Seniority level Entry level
Employment type
  • Employment type Full-time
Job function
  • Job function Quality Assurance
  • Industries Technology, Information and Internet

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