Job Description
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Supporting routine analytical testing with assays such as HPLC, CE, UV, Compendial, PCR and ELISA techniques on Release, In-process, Raw Materials and Stability samples.
- Lead technical Laboratory Incidents, Investigations and Problem Solvings.
- Lead local change controls and participate as a laboratory SME for changes in the network which impact the laboratory.
- Author, Review and Approve technical writing activities such as Protocols, Reports and procedures.
- Participate and lead Continuous improvement and Laboratory transformation projects.
- Support Divisional, Regulatory and EHS audits as an SME in your area on site.
- Play a key role in the troubleshooting and escalation process on site.
- Calibrate and maintain all designated laboratory instruments.
- Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
- Ensure training is current for all job functions performed.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Promote and participate the implementation and maintenance of the relevant safety programmes.
- Maintain MPS/Lean Lab standards within the laboratory.
- Support with various QC related Initiatives.
- Maintain good housekeeping and hygiene within the laboratory.
What skills you will need:
In order to excel in this role, you will more than likely have:
- A bachelor’s degree (or higher) in Natural Science/Chemical Engineering/Biological Engineering.
- Minimum 4-7 years’ experience in the pharmaceutical industry.
- Experience in performing Laboratory testing with a good understanding of relevant Analytical techniques.
- Experience in Technical writing (Investigations, Procedures, Change Controls etc.)
- Project participation and leading experience.
- Experience in participating in audits as an SME (Subject Matter Expert)
- Working knowledge of Six Sigma and Lean methodologies.
- Knowledge of GMP practices.
- A working knowledge of ICH guidelines and global pharmacopeial requirements.
- Experience using laboratory software (Empower 3, LIMS, SAP etc.)
So, if you are ready to:
Current Contingent Workers apply
Not Applicable
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.