Description

• 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
Planning and Procedures

• Plan and prioritize 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 authorizations
• 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
• Optimize 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

Skills Required

Background/experience

• Minimum of bachelor’s degree preferred, ideally in Pharmacy
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience
• Registration with Pharmacy Council
• 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
• Finalizing output
• Taking action