PMA (Contract position)
Not specified, Contract Deadline: Not specified
Description
Overview
Monitor and report on manufacturing compliance to GMP and statutory requirements
Ensure adherence to guidelines, procedures, document controls and support with related administrative task
Requirements
Responsibilities
Inspections and Verifications
Perform visual inspections of rooms, machine parts and equipment
Verify that rooms and equipment are certified clean as per SOP
Verify scale and measuring equipment performance and daily calibration as per SOPs, protocols and schedules
Verify daily sampling, dispensing of materials and its mass/ volume
Perform housekeeping of rooms and equipment
Line ’ Production processing
Perform line sign-on and closure
Check and authorise packaging line clearance
Order and maintain substance materials
Perform batch reconciliations to product specifications and quality
Monitor production process in line with standards and specifications
Process and system improvements
Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
Manage and resolve customer complaints
Optimise processes and identify gaps in policies/ procedures
Compliance ’ Auditing
Conduct shift GMP checks and ensure continued compliance
Conduct environmental checks and check expiry dates of agents
Verify good document practice as per SOP and regulation
Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
Verify IPCs are in line with product quality and specifications
Check preliminary batch records
Audit logbooks and systems
Troubleshooting
Investigate deviations and concessions and assess risk
Raise deviations and implement corrective action
Raise maintenance notifications as and when required
Training and technical expertise
Train new PMAs on SOPs
Identify refresher or awareness training needs
Administration ’ Record keeping
Complete batch records and labels
Complete deviation forms as required
Query documents and sign off declarations
Perform and verify calculations in BMR
Maintain and update records and systems as required
Skills Required
Background/experience
Post Basic Registration with the Pharmacy Council
1-3 years’ related experience in manufacturing
Pharmaceutical manufacturing and/ or Pharmacist Assistant experience
Specific job skills
Basic technical knowledge of pharmaceutical manufacturing, standards and compliance requirements
Ability to interpret and implement policies, processes and objectives
Competencies
Interrogating information
Meeting deadline
Finalising outputs
Maintaining accuracy
Competencies
Interrogating information
Meeting deadline
Finalising outputs
Maintaining accuracy
Accountability and Decision Rights
Timely and accurate performance of responsibilities for a single technical area or group of closely related tasks, under supervision
Learn and implement policies, procedures, quality and compliance standards
Recognise and resolve basic, routine or common/ repetitive problems
Seek assistance on complex issues and referring non-prescribed matters
Stay up to date on legislation and industry regulations
Decisions relating to
Own work, within limited, defined parameters
Prioritisation of basic tasks, with clear guidance