Job Summary Broad Purpose / Function: Four different pillars to achieve the above goal:
Day-to-Day Support: The Production Pharmacist (PP) is responsible to properly support the production area to ensure in-compliance support where needed (e.g. line opening, line closing)
Process Knowledge: The PP has to understand the production processes for which he/she is responsible
This scopes scientific understanding of the process, knowhow on production equipment within the process and identifying risks to ensure execution in compliance
Product Stewardship: This pillar scopes basically the ownership of the product as well as the GMP documentation in the area of responsibility
The PP will monitor the processes to ensure they are capable and in control, will lead or coordinate any changes (change controls, transfers, etc) and will lead root cause investigation in case deviations happen
The PP is also responsible to ensure that all processes are qualified
Continuous Improvement: The PP should lead actions to improve the production processes and achieve leaner and more efficient practices
For this, the PP will identify improvement areas, evaluate risks and execute following Good Documentation Practices e.g. Change Control
Duties / Responsibilities:
Based on the four pillars: Day-to-Day Support:
Ensure that procedures and process within area of responsibility are performed in accordance with relevant Standard Operating Procedures, Work Instructions and current Good Manufacturing Practices
Drive and support close out of all relevant compliance related audit findings
Responsible for performing line-openings and in process checks according to legislative and company requirements
Update GMP documents (SOP, WI, PPI and PI etc), as required and train accordingly
Ensure effective communication to all relevant parties
Ensure all production documentation and processes are completed as per cGMP guidelines
Interact with cross functional teams to support
Understand process flow
Understand process controls as well as risks
Understand technically the product and its composition
Understand process/product cost structure
Support training to operators
Process Knowledge
Product Stewardship
Ensure GMP, EHS and Quality compliance during the execution of the Plan and all related tasks. Ensures compliance with work instructions according to the relevant SOP's
Initiate, investigate and close out relevant GMP and SOP compliance related NC, CAPA, Change Controls, Deviations and Customer Complaints.
Support process transfers (in or out)
Perform in process audits xe2x80x93 both planned and ad hoc accordingly to ensure that GMP standards are met and maintained.
Support regulatory with technical documents
Continuous Improvement:
Drive, contribute and support continuous improvement initiatives of GMP compliance and standards within the department accordingly and together with the management team
Analyze the process on a routine basis to identify risks or inefficiencies
Lead the execution of Improvement Projects in the area of responsibility
Plan the implementation of improvement projects
Perform internal assessments in production areas and develop corrective actions to strengthen cGMP
Qualifications / Experience / Requirements:
Registered with SAPC as a qualified Pharmacist.
1-2 years pharmaceutical manufacturing experience
Supervisory experience/qualification will be an added advantage
Good knowledge and understanding of the SA cGMP Guide
Good planning and administrative competencies
Good verbal and written communication
Logical approach to problem solving and trouble shooting
High work standards and business ethics
Must be available to work shifts if required
Skills:
Interpersonal skills; Active listening, provides constructive feedback, team player, communication skills Drives accountability in the area of responsibility. Encourages input from the team on decisions Management skills Deadline and target driven approach and behaviour User knowledge of Microsoft Office Please note only successful candidates who matches the criteria will be contacted
Manpower Group
Recruiter
Job Mail
Beware of fraud agents! do not pay money to get a job
MNCJobs.co.za will not be responsible for any payment made to a third-party. All Terms of Use are applicable.