Production Pharmacist at Aspen Pharma Group

Overview

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures, and document controls
• Deliver expected productivity targets as per business requirements
• Related administrative tasks
• Serve as back up to Team Leader on shift

Requirements

• Responsibilities Planning and Procedures
• Plan and prioritise daily, weekly and monthly activities
• Determine, request and use resources/ assets optimally Inspections and Verifications
• Verify schedule 5 products Verify certified clean status of rooms and equipment
• Verify, review and approve verification of measuring equipment performance, calibrations and sampling, and dispensing of materials Line & Production processing
• Perform, review and approve line sign-on’s, closures and clearance authorisations
• Perform, review and approve batch reconciliations to product specifications and quality
• Ensure production process adherence to standards and specifications Process and system improvements
• Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
• Manage and resolve customer complaints
• Optimise processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus Compliance & Auditing
• Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
• 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
• Review and approve 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 Pharmacists and PMAs on SOPs in transition period
• 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
• Retrieve supporting documentation and records to facilitate and support query resolution

Requirements Background/experience

• BPharm Degree
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience 
• Specific job skills Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives Competencies
• Information gathering
• Interrogating information
• Meeting deadlines
• Finalising output
• Taking action Accountability & Decision Rights
• Work on assignments of moderate size, scope, diversity and/ or complexity
• Seek guidance when needed Decisions relating to:
• Own work methods, occasionally in ambiguous situations, guided by precedent, previous experience and known professional guidelines/ compliance requirements
• Interpretation of policies, standards, requirements and approaches

Closing Date: 22 February 2023