Production Pharmacist

About the position

Production Pharmacist

Support production (dispensary, manufacturing, packaging and distribution) processes to ensure these that these processes are compliant, reliable and efficient.
 
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.
Essential duties and responsibilities

Day-to-Day Support:
Ensure that procedures and processes 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.

Process Knowledge
 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

Product Stewardship
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 – 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

Desired Skills:

• Pharmacist
• Production Pharmacist
• Production
• SACP