Process Specialist – £22k

  • Llandysul, Wales
  • £22k
  • dh 22
  • 01267 610 902

Job Description

Process Specialist -£22k
Our Client is a growing international specialist healthcare company with facilities in West Wales, the Home Counties, Europe and the USA. Our mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients.
 
The Process Specialist will be responsible for providing technical expertise to the Production team.  Ensure the technical content of Production quality documentation (SOPs, QRs, RCAs, CMNs, Quality Events) is to an appropriate standard and be a key individual in investigations into quality events within the team to ensure maintenance of the Production schedule.  Responsible for providing appropriate training to the team to ensure level of process and product understanding is contained.

Principal Responsibilities

  1. Responsible for maintaining the standard of the quality system documents generated by the Production team.  Key individual for batch record review, quality events and change controls, ensuring quality records and SOPs are accurate and actions closed within the allotted timeframe.
  2. Provide technical input into validation activities for the Production team – write, review, approve and execute studies as required.
  3. Lead technical representative at site cost improvement initiatives (VIPs and CoGs).
  4. Work alongside Manufacturing Technical Support to transfer new equipment and techniques to production scale.
  5. To foster and encourage Continuous Improvement within the Production department. Lead process improvement initiatives and activities to influence change.
  6. To actively maintain and update knowledge and expertise of current developments, standards and operating practices within the biotechnology and pharmaceutical industries
  7. Input into the Regulatory strategy and author the relevant sections of Regulatory dossiers.
  8. Ensure practical training modules are in place so that new starters within the teams are provided with sufficient background understanding and knowledge before entering into their roles.  Responsible for the provision of training to new starters and for robust re-training modules to maintain a high compliance within the teams.
  9. Provide subject matter expert input to Regulatory, internal and external audits.
  10. Cover operator absence within the facility as required.
  11. Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with the Client’s values.
  12. Carry out other reasonable tasks as required by the Line Manage

Principal Relationships

  1. Accountable to – Process Specialist Lead.
  2. Interaction with internal personnel at all levels of the business as required.
  3. Liaise with external personnel as required.

Education and Experience

  1. Educated to degree level in an appropriate scientific discipline.
  2. Significant experience in a biopharmaceutical or closely related industry.
  3. Excellent understanding of cGMP legislation
  4. Computer literate.

Skills and Attributes

  1. Strong technical background with an excellent working knowledge of GMP, Quality and Regulatory understanding.
  2. Must have good listening/communication skills and be able to carry out investigations by gathering information from others.
  3. Needs to be methodical, organised and show attention to detail. Organisational skills should be strong with an ability to plan ahead
  4. Strong technical writing skills
  5. Ability to communicate effectively at all levels
  6. Ability to work under pressure and co-ordinate several activities concurrently.
  7. Project management capabilities
  8. Strong presentation skills
  9. Logical and numerate with an aptitude for detail.
  10. A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward.

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