{"id":13968,"date":"2013-09-02T11:31:48","date_gmt":"2013-09-02T09:31:48","guid":{"rendered":"https:\/\/joblistsouthafrica.com\/?p=13968"},"modified":"2013-09-02T11:31:48","modified_gmt":"2013-09-02T09:31:48","slug":"qa-officer-laboratory-formulations","status":"publish","type":"post","link":"https:\/\/joblistsouthafrica.com\/qa-officer-laboratory-formulations.html","title":{"rendered":"QA Officer Laboratory & Formulations"},"content":{"rendered":"
Reporting to:\u00a0Regulatory and QA Manager<\/p>\n
Job Purpose<\/strong><\/p>\n 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.<\/p>\n \u2022 BSc Chemistry, ND Analytical Chemistry or equivalent \u2022 Implementation and continual improvement of the laboratory and formulation QMS \u2022 Ability to work as part of a team and on own initiative
\n\u2022 Minimum of 10 years pharmaceutical experience or R&D environment.
\n\u2022 In depth knowledge of analytical development, formulation development, qualifications and validations, cGLP, Quality Assurance
\n\u2022 Thorough knowledge of MCC and all relevant ICH Guidelines and Pharmacopoeias
\n\u2022 Good knowledge\/experience of analytical instrumentation and qualification procedures<\/p>\n
\n\u2022 Review and approval of formulation and analytical development data and reports, including technology transfer documentation
\n\u2022 Training of staff with aspects related to process, troubleshooting, deviations, OOS including related documentation
\n\u2022 Review and approval of master manufacturing and packaging documentation
\n\u2022 Process validation of manufacturing processes and the generation of the validation reports as per current regulatory guidelines
\n\u2022 Generate Risk Assessment Reports and conduct special investigations\/root cause analysis
\n\u2022 Update and or initiate relevant Standard Operating Procedures
\n\u2022 Perform department audits and follow ups
\n\u2022 Handle ad-hoc requests for validation documentation and other related tasks<\/p>\n
\n\u2022 Excellent decision making and problem solving skills
\n\u2022 Excellent planning and organising skills
\n\u2022 Excellent verbal and written skills
\n\u2022 Strong analytical and problem solving ability
\n\u2022 Excellent inter-personal and communication skills
\n\u2022 Good time management skills
\n\u2022 Excellent leadership skills
\n\u2022 Proficient computer skills (MS Office, MS Excel)<\/p>\n