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Production Specialist

2 months ago

Stirling, Stirling, United Kingdom SRG Full time

Job Title: Production Specialist - Pharmaceutical Sterile Operations

Location: Stirling

Contract Type: Permanent

Working Schedule: Shifts (7am to 2pm / 3pm to 10pm) - candidates must have reliable transportation or reside nearby

Core Objective:

The Production Specialist plays a vital role in the creation of pharmaceutical products within a sterile (aseptic) setting, ensuring that all procedures comply with regulatory requirements and enhance operational productivity.

Primary Duties:

Operational Excellence

  • Implement production processes for sterile products from raw material procurement to final product delivery, adhering to cGMP and SOPs.
  • Maintain validated aseptic cleanroom operator credentials; prepare materials, manage supplies, label, and package products.
  • Conduct regular cleanroom assessments and equipment preparations for production.
  • Execute filtration of bulk pharmaceutical solutions and perform integrity assessments, managing both liquid and lyophilized drug products.
  • Reconcile materials and conduct sampling of completed products.

Regulatory Compliance & Quality Assurance

  • Ensure a clean and safe work environment in accordance with GMP and Health & Safety regulations.
  • Assist in Corrective Action/Preventative Action (CAPA) processes, deviation investigations, and out-of-specification evaluations.
  • Support the validation and qualification of equipment and processes as necessary.

Team Management & Development

  • Facilitate the onboarding of production personnel, ensuring clarity in their responsibilities and alignment with organizational objectives.
  • Provide guidance, feedback, and collaboration with team members to improve performance and operational efficiency.

Relationship Management

  • Engage in staff and management discussions to share insights and updates on production activities.
  • Build relationships across teams and management to ensure seamless operations and meet service standards.
  • Act as a representative of the organization, fostering a positive image of the company.

Candidate Profile:

Qualifications

  • Essential: Minimum of 5 National 5's or Higher in Mathematics and English.
  • Desirable: Degree in Life Sciences.

Experience

  • Essential: Proven experience in meticulously following production documentation in a GMP-regulated cleanroom environment.
  • Desirable: Familiarity with pharmaceutical production and lean manufacturing principles.

Skills

  • Strong communication abilities to collaborate effectively within a team.
  • Adaptability and flexibility to manage multiple tasks efficiently in a fast-paced environment.

Working Schedule:

This position follows a 2-week shift rotation:

  • Week 1: 7am - 3pm
  • Week 2: 2pm - 10pm