Sterile Operations Director

1 day ago

Dublin, Dublin City, Ireland beBeeOperations Full time

About the Role:

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The Sterile Operations Director is responsible for overseeing the daily operations of a sterile manufacturing environment, ensuring compliance with global regulatory standards and company policies. This role leads the planning, organization, and execution of filling operations, ensuring optimal performance, productivity, and quality.

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Key Responsibilities:

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  • Plan and organize job assignments in alignment with production schedules and cGMP requirements.">
  • Ensure equipment is operated, cleaned, and maintained according to established procedures.">
  • Oversee process control adjustments and maintain accurate records/logs.">
  • Manage employee performance, development, and attendance.">
  • Counsel team members, delegate effectively to senior staff to build capability.">
  • Conduct annual and mid-year performance reviews.">
  • Ensure timely, consistent, and effective training for all team members.">
  • Promote a culture of safety, integrity, and collaboration.">
  • Serve as a subject matter expert for troubleshooting and maintaining optimal process parameters.">
  • Investigate and resolve process deviations, documentation errors, and related issues.">
  • Ensure strict adherence to cGMPs, company policies, and safety rules.">
  • Support and facilitate regulatory inspections and audits.">
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Requirements:

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  • Bachelor's degree in a related field.">
  • Minimum 5 years' experience in pharmaceutical, bioscience, or medical device manufacturing.">
  • Minimum 5 years' management experience leading a team of 10 or more.">
  • Lean or Six Sigma certification preferred.">
  • In-depth knowledge of sterile product manufacturing regulations for global markets.">
  • Proven ability to lead and prepare teams for regulatory body audits.">
  • Strong understanding of cGMP requirements.">
  • Excellent leadership and team development skills.">
  • Strong problem-solving and analytical abilities.">
  • Effective communication and presentation skills.">
  • Proficiency in Microsoft Office Suite.">
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We Offer:

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  • Highly competitive salary">
  • Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%)">
  • Private Medical Insurance for the employee">
  • Ongoing opportunities for career development in a rapidly expanding work environment">
  • Succession planning and internal promotions">
  • Wellness activities - Social activities eg. Padel, Summer Events">
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Equal Opportunities Employer:

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We welcome applications from talented individuals who meet the qualifications.

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