QA Technical Support Coordinator

Purpose:

A global pharmaceutical organisation is urgently seeking a QA Technical Support Coordinator to join their organisation, who will be responsible for providing technical support to all the departments at R&D to ensure compliance with MCC, WHO, GAMP and ICH Guidelines

Key Job Outputs:

Initiate change requests and determine which categories of change should be included in the system
Ensures that change requests are approved by authorized approvers and are filed in the correct locations with the organisation
Ensures that labelling specifications are initiated to fulfil MCC, Baxter requirements and follow up on processing of artwork with suppliers
Ensure appropriate action is taken when handling a non-conforming label copy
Prioritizes initiation, typing, circulation of change request within the department
Maintain product history files as per SOP and archive completed projects, protocols and history files
Ensure that project documentation and protocol requirements are met
Liaise with Baxter USA for new codes and drug applications

Co-ordinates BPCS and Oracle BOMs for all products
Ensures that BOMs and Item masters are initiated, updated, maintained and obsoleted
Initiate and manage required change controls for the company
Training of Concurrers and Approvers and evaluates the competency of Concurrers and Approvers
Evaluate and approves changes of SOPs, Specifications, BOMs, Protocols and PL Cards
Complete audit reports for all relevant departments to inform state of files
Ensures conformance to the OHS Act and the organisation’s SHE procedures
Continually improves the effectiveness of the organisation’s Quality Management System
Prepares Expenses and Capex budgets for the financial year
Determines the required staff complement to adequately man the department
Management of staff to ensure efficiency and productivity within the department
Core Competencies:

Ability to work as part of a team and on own initiative
Ability to interpret and implement guidelines
Excellent decision making and problem-solving skills
Excellent planning and organising skills
Excellent verbal and written skills
Strong analytical ability
Good time management skills
Excellent leadership skills
Excellent computer skills
Accurate typing proficiency
Excellent inter-personal and communication skills
Qualifications:

BSc Chemistry, ND Analytical Chemistry or equivalent
Experience:

5 years of Pharmaceutical experience or related discipline
A combination of experience and/or education will be taken into consideration
Thorough knowledge of GMP's
Demonstrate success in completing projects
Good understanding of analytical and manufacturing processes
Ability to interpret analytical data
Thorough knowledge of Computer system validation
Expertise in Excel validation and statistics
Working knowledge of pharmaceutical regulations
Experience in compilation of analytical methods, specifications and reports
Execute process validation for pilot trial batches
Team player with strong interpersonal skills and a good communicator both verbally and written
Excellent proficiency in Word, PowerPoint
Salary: Market related

Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful.


Apply Here http://bit.ly/2wcLVX5

Job id : , #70710, 6 views,

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