QC Analyst - Day

at  Piramal Pharma Solutions

Falkirk, Scotland, United Kingdom -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate23 Jan, 2025Not Specified24 Oct, 2024N/AGood communication skillsNoNo
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Description:

Responsibilities:

  • Perform batch disposition and stability activities in a proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products and
  • stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good
  • Documentation Practices for Electronic Data.
  • Perform stability study programme activities, storage of in process, and final products samples and retention sample management
  • System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.
  • Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents
  • Preparation and update of SOPs, instructions and protocols and other Quality Control documentation
  • Checking and reviewing of data in compliance with Data Integrity requirements
  • Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
  • Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration
  • Maintain Quality Control information systems
  • Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst
  • Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.
  • Attend internal and external scientific and technical meetings and conferences where appropriate
  • Carry out general maintenance and house keeping of equipment and laboratories
  • Available to provide cover for other departments within the organisation as required
  • Available to undertake any other duties as requested by the QC Manager in accordance with Company requirements.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Falkirk, United Kingdom