QA Officer Laboratory & Formulations

Reporting to: Regulatory and QA Manager

Job Purpose

Ensure that an effective QMS is initiated and maintained to meet all regulatory requirements and quality assurance standards. Responsible for review, assessments and training of all laboratory and formulation development activities, including process validations and self-inspections. Assist with projects on an on-going basis.

• BSc Chemistry, ND Analytical Chemistry or equivalent
• Minimum of 10 years pharmaceutical experience or R&D environment.
• In depth knowledge of analytical development, formulation development, qualifications and validations, cGLP, Quality Assurance
• Thorough knowledge of MCC and all relevant ICH Guidelines and Pharmacopoeias
• Good knowledge/experience of analytical instrumentation and qualification procedures

• Implementation and continual improvement of the laboratory and formulation QMS
• Review and approval of formulation and analytical development data and reports, including technology transfer documentation
• Training of staff with aspects related to process, troubleshooting, deviations, OOS including related documentation
• Review and approval of master manufacturing and packaging documentation
• Process validation of manufacturing processes and the generation of the validation reports as per current regulatory guidelines
• Generate Risk Assessment Reports and conduct special investigations/root cause analysis
• Update and or initiate relevant Standard Operating Procedures
• Perform department audits and follow ups
• Handle ad-hoc requests for validation documentation and other related tasks

• Ability to work as part of a team and on own initiative
• Excellent decision making and problem solving skills
• Excellent planning and organising skills
• Excellent verbal and written skills
• Strong analytical and problem solving ability
• Excellent inter-personal and communication skills
• Good time management skills
• Excellent leadership skills
• Proficient computer skills (MS Office, MS Excel)

How to Apply

Click on this link to apply online

Saturday, 14 September 2013