Description:
Plan, manage and supervise the activities of the laboratory and its analysts. Perform all analytical testing and ensure their delivery in an accurate and timely fashion using proper cGMP & safety precautions. Provide day to day technical and administrative support.
Essential Duties And Responsibilities
- Supporting the Laboratory Manager in generating and executing on Instrument Qualification protocols or test method transfer protocols, generating standard Operating Instructions or implementing workflows.
- Supervising a group of Analysts, with the goal of performing all analytical testing that is required to support plant operations. This includes batch release testing as well as testing of incoming materials such as Sterilisable Bags or raw materials.
- Analytical testing will cover wet chemical analysis, modern spectroscopic and chromatographic methods as well as functional testing.
- Implementing processes and procedures to ensure on-time delivery of testing in compliance with cGMP, the relevant Regulatory Guidelines/Industry Standards and the relevant local and global Safety Guidelines.
- Guiding customer audits in the analytical laboratory area.
- Investigating OOS/OOT results and implementing CAPAs related to analytical testing.
- Executing/supporting qualification/validation activities within the laboratory, production clean rooms or water systems, e.g. cleaning validations.
- Supporting other functions (e.g. R&D, TCS, process engineering) as a Subject Matter Expert
- Contributing to the harmonization of test methods, equipment, infrastructure, etc. based on the strategy of the global West laboratory organization.
- Developing/implementing new test methods in alignment with global West laboratory strategy.
- Approval of Documents in the Laboratory Supervisor’s (Micro/Particle) absence: SOIs, ESOPs, EWIs, Attachments, Protocols, Reports, Strategy documents, Risk Assessments, OOS investigations, Deviations.
- Lead in the continuous improvement of Laboratory processes – playing an active and key role supporting the team in continuous improvement initiatives/projects.
- Responsible for the execution of training for the team; identification of training requirements for the team.
- Manage the team’s performance, conduct performance 1 to 1’s, support recruitment, training and development plans while addressing any issues that arise in a timely manner.
- Own the development process for each team member. Delegation of development objectives and activities assigning tasks, reviewing work and completion of appraisals in line with the company targets.
- Maintain a positive employee relations atmosphere. Ensure that there is good communication and co-operation by encouraging knowledge sharing.
- Compliance to all site Environmental, Health and Safety requirements, training and regulations.
- Compliance to all local site company policies, procedures and corporate policies.
- Act in accordance with the company’s Guiding principles and adherence to the Corporate Code of Conduct.
- Other duties as assigned
Education
- Bachelors Degree in Science/Chemistry is required
Work Experience
- Minimum 5 years’ experience in a similar role (analytical testing) within the pharmaceutical/medical devices/manufacturing industry.
- Experience in a cGMP environment.
- Strong competence in IT
- Good verbal and written communication skills
- Excellent interpersonal skills with the ability to work with all levels within the organisation.
- Team player.
- Structured way of working & strong organisational skills
- Ability to interact with suppliers, customers and external contractors.
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target