Discover Bristol Laboratories

As a dynamic, growing company, we are always looking for the best people to join us. Please take a look at our list of current vacancies and discover what Bristol Laboratories has to offer.

If any of the positions interest you, please e-mail your details to :  hrd@bristol-labs.co.uk

Quality Control/ Analytical Development Analyst- Vacancies in Luton and Peterlee

 Key Responsibilities:

  • Testing of all laboratory samples including raw materials, in-process, finished products,
  • Validation, stability, environmental (as per written procedure or as per pharmacopeia).
  • Ensuring all cGMP/GLP requirements are strictly adhered to and that SOP’s are followed at all times
  • Recording of analytical results accurately.
  • Operation, maintenance and calibration of laboratory instruments.
  • Maintaining usage of laboratory chemicals and keeping records.
  • Preparation and execution of instrument qualification and method validation protocols.
  • Ensuring that the laboratory is kept clean, tidy and safe at all times.
  • Report any non-conformance, instrument malfunction, accident or other abnormal occurrence to immediate superior.
  • Verify analytical data and carryout  documentation as required
  • Troubleshoot equipment and methods as required.
  • Participate in internal audits of GMP and Health & Safety.
  • facilitate and participate in self inspections, internal quality audits, customer audits and regulatory inspections
  • Ensuring individual training record is kept up to date.
  • Development of analytical methods for assay, dissolution and related substances
  • Monitoring of stability studies for dossier products
  • Calibration of sophisticated analytical instruments
  • Maintaining the good documentation in the analytical department
  • Analytical validation for finished products
  • Support the process validation for site transfer
  • Analysis of product development trials from R&D
  • Preparing analytical method development, validation and test reports.

Requirements:

  • Academic achievement to minimum Graduate Degree level in a Science based discipline.
  • Firm understanding of cGMP procedures in a pharmaceutical manufacturing unit
  • Excellent verbal/written communication and interpersonal skills
  • Competent computer skills (Microsoft Office, Excel etc.)

Research and Development Manager- Vacancies in Luton and Peterlee

Key Responsibilities

  • Oversees the R&D department at a specific manufacturing site, in conjunction with the R&D Head
  • Develop Pharmaceutical dosage forms & specialty formulations comprising of oral liquids, modified release tablets etc. for both OTC and Generic drug markets.
  • To supervise formulation development and technology transfers to commercial production
  • Co-ordinate process validation for the products developed for commercial production.
  • Authors, reviews and approves GMP-critical documentation, including batch records, amendments, experimental summaries, and qualification/validation reports.
  • Co-ordinate bio-equivalency studies, prepare and implement standard operating procedures and related documentation
  • Leads one or more projects and teams in support of departmental plans.
  • Leads outsourcing of manufacturing processes/technology transfers
  • Manage team of experienced R&D chemists and supervise plant employees carrying out R&D projects
  • Ensures adherence to organizational policies and procedures including design controls and the product development process.
  • Lead process optimization projects with a focus on product quality and production efficiency
  • Coaches R&D scientists in defining and implementing innovative solutions for assigned tasks, balancing achievement of milestones with high quality standards.
  • Develops strong collaborative relationships with other internal departments/groups. Fosters an environment of knowledge sharing
  • Should have working knowledge of tablet presses, encapsulation machines, granulation and blending equipment.
  • Demonstrates hands-on experience conducting R&D trials.

Requirements

  •  A master’s degree in a scientific discipline or PhD with significant experience leading the development of solid, liquid, creams & ointments.
  • Proven technical leadership skills with experience using engineering/scientific principles to develop or improve products and/or validate processes.
  • Proven experience as a project manager with good supervisory and teamwork skills in a fast paced and challenging environment
  • Good knowledge and understanding of GMP standard and requirements in EU
  • Excellent verbal/written communication and interpersonal skills

Senior Quality Assurance Manager- Vacancies in Luton and Peterlee

Key Responsibilities:

  • Drive and lead the Quality Assurance (QA) team (QA systems, validation and Quality Control) to achieve targets and aspects of the overall business vision.
  • Managing the overall quality of the product and Quality Management System (QMS) by making sure it is manufactured, tested and released to GMP standard.
  • Provide overall positive expertise and timely direction of customer audits, CAPA’s, regulatory expectations and batch reviews. The compliance and lean standards of the site must be upheld as well as full ownership and execution of the Site Validation Master Plan
  • Plans audit calendars and leads GXP audits of CMOs, CROs, distributions centres and other service providers
  • Manage self-inspections , Internal quality audits and ensure its compliance
  • Interface with Regulatory Affairs and Manufacturing regarding change control and corrective action/preventative action (CAPA) associated with GXP operations
  • Review and approval of calibration /Qualification/Validation protocols, reports and ensure its execution
  • Oversee Quality management systems across the organization and carry out root cause and trend analysis (e.g. OOS/OOT, Deviation, PQR management, Change control)
  • Develop training materials and delivering training to colleagues and stakeholders
  • Keeping site in compliance for all time readiness for any regulatory audit.
  • Should have demonstrated knowledge and experience in the interpretation and application of cGMPs and ICH requirements for both domestic and international territories
  • Knowledge of GCPs and Pharmacovigilance standards desirable
  • To develop effective relationships with other global quality groups colleagues and other company stakeholders (including Legal, Operations, Regulatory, Medical functions)
  • Assist in management of document management system and proactively initiate SOP update activity where required from periodic SOP cycle reviews
  • Prepare metric data related to support management review process

Requirements:

  • Post graduate degree or degree level in either a relevant scientific field (i.e pharmacy, chemistry, Pharmaceutical Management) with significant relevant quality management experience in a GMP compliant Pharmaceutical company.
  • Experience working closely with the Quality Management System (QMS), leading a team and involved directly interacting with the regulatory authorities with respective to regulatory inspections is expected.
  • Those with experience in Lean / Six Sigma improvement methodologies will be desirable however not essential
  • Firm understanding of Quality Assurance activities /cGMP/cGLP and QMS procedures in a pharmaceutical manufacturing unit as well as in warehousing and distribution
  • Good knowledge on Pharmaceutical Microbiological activities is desired but not mandatory
  • Excellent understanding of European regulatory environment
  • Excellent organisational, coordination and presentation skills
  • Excellent verbal & written communication and interpersonal skills

Pharmaceutical Packaging Manager- Vacancies in Luton and Peterlee

Key Responsibilities:

  • Manage and co-ordinate the activities of all staff in pharmaceutical packaging department
  • Maximize yield and improve process efficiency through teamwork, problem solving and continual improvement
  • Resolving quality issues, including reducing customer complaints
  • Manage all packaging validation activities, responsible for reviewing packaging qualification and validation documents
  • Produce, maintain, review, evaluate and sign- off production documentation and ensure compliance with regulatory requirements and internal standards
  • Ensure that staff training and development is fulfilled and to monitor staff progress through maintenance of training records and regular appraisals.
  • Be actively involved in identifying machine improvements and optimising usage to maximise output
  • Ensure equipment is used under the necessary certificates of validation, calibration and maintenance.
  • Lead and encourage staff to improve Health and Safety and GMP compliance.
  • Introduce new business requirements, systems, equipment, etc as required (ie serialisation).
  • Proven ability and desire to manage high-priority, time-sensitive projects concurrently
  • Maintaining knowledge of current cGMPs and associated regulatory considerations in a commercial pharmaceutical packaging environment

Requirements:

  • Scientific degree or significant experience within a pharmaceutical manufacturing environment
  • Good knowledge and understanding of GMP and Health & Safety
  • Excellent verbal/written communication and interpersonal skills
  • Experience of SAP (or equivalent system) and competent computer skills (Microsoft Office, Excel etc.)
  • Strong leadership traits and be competent in people management
  • Good organizational and strategic planning skills
  • Ability to excel in a dynamic, fast-paced work environment

Supply Chain and Distribution Manager-Vacancies in Luton and Peterlee

Key Responsibilities:

  • To assess all the factors of supply chain such as strategic planning, distribution, logistics, order management, warehouse space management and information systems.
  • Liaising with customers, suppliers and transport teams, planning, coordinating and monitoring the receipt, order assembly and dispatch of goods.
  • Monitoring compliance to GDP procedures.
  • Manage and control operational costs in an effective manner.
  • Take responsibility for Staff recruitment/retention and ensure regular training is carried out for the team.
  • Maintain a safe working environment which complies with all aspects of the company’s H&S policy.
  • Attending and facilitating regular operational meetings with staff to communicate consistent objectives and performance.
  • Establish, monitor and maintain agreed performance levels for all warehouse activity.
  • Maintain and review all procedures for efficiency and continuous improvement in operations

Requirements:

  • Experience of managing a warehouse environment in a highly regulated industry in the capacity of supply chain & distribution manager.
  • Ability to excel in a dynamic, fast-paced work environment
  • Good understanding of the importance of the warehousing operation in a manufacturing environment
  • Good Distribution Practice knowledge would be preferable
  • Excellent verbal/written communication and interpersonal skills
  • Experience of SAP (or equivalent system) and competent computer skills (Microsoft Office, Excel etc.)
  • Ability to embrace change and to drive forward and deliver operating plan objectives
  • Strong leadership traits and be competent in people management
  • Experience in Health & Safety training e.g. an IOSH Managing Safety qualification (not mandatory)
  • Good organizational and strategic planning skills

Research and Development Scientist-Vacancies in Luton and Peterlee

Key Responsibilities

    • Carry out extensive literature search
    • Be part of projects for the development of new product
    • Contribute to Product Scale Up and Technology Transfer
    • Conducting Process Optimization and validation
    • Prepares GMP-critical documentation, including batch records, amendments, experimental summaries, and qualification/validation reports.
    • Perform follow up on analytical results
    • Assisting in Preparation and execution of PDR( Product Development Report ) for regulatory submission
    • Trouble Shooting at shop floor and product improvisation
    • Provide Technical support to other related functions like Quality, Production, Regulatory, Marketing, Costing and Purchase etc.

Requirements

  • Degree/ Master’s degree in a scientific discipline with minimum 3 years’ experience in pharmaceutical industry
  • Good knowledge and understanding of GMP standard and requirements in EU
  • Excellent verbal/written communication and interpersonal skills

Production Manager-Vacancies in Luton and Peterlee

Key Responsibilities

    • Supervise the on-the-floor operations of our manufacturing facility in a cGMP environment
    • Provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
    • Ensuring department outputs (KPI’s) are met and that established cGMP quality standards are adhered to at all times
    • Work closely with supervisors and operator staff to plan work, set targets and make sure the finished products meet quality standards
    • Work actively with Production, Maintenance, QC, QA and Validation to monitor and optimize use of plant capacity to ensure product delivery to agreed customer deadlines
    • Represent the Manufacturing Department in quality investigations including but not limited to the handling of deviations, complaints, out of specification investigations, corrective and preventative actions for deviations, material disposition investigations and change control.
    • Manage, verify and control the arrival of components and materials necessary for Production.
    • Ensure that plans match with budget and inventory expectations – escalating any discrepancies within the business.
    • Ensure that all manufacturing equipment are validated, calibrated, and maintained according to SOPs.
    • Write, review and approve documentation pertinent to manufacturing operations
    • Ensure implementation and compliance of cGMP guidelines for all production related operations
    • Complete the final review of completed manufacturing documentation per compliance standards and established timelines.

Requirements

  • Scientific degree or master’s degree
  • Significant experience within a pharmaceutical manufacturing environment (minimum of 5 years)
  • Good knowledge and understanding of GMP and Health & Safety
  • Excellent verbal/written communication and interpersonal skills
  • Experience of SAP (or equivalent system) and competent computer skills (Microsoft Office, Excel etc.)
  • Strong leadership traits and be competent in people management
  • Good organizational and strategic planning skills
  • Ability to excel in a dynamic, fast-paced work environment
  • Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management