Specialist, Validation

 

Main purpose of role:

• To ensure process validation activities at the contract manufacturer has been carried out as per current GMP standards and best industry practices in line with Marketing Authorisations (MA).  

• To obtain and review existing process and analytical method validation reports from Contract manufacturer and ensure they meet current GMP standards.  

• To highlight gaps identified in existing validation reports and work with relevant departments / contract manufacturer on remediation plan to mitigate the risk.  

• Stay updated on recent changes in guidelines and ensure ADVANZ PHARMA’s Operations Systems and procedures comply with current legislation as and where applicable. 

• To participate in preparation of monthly metrics and support in presenting the team KPIs wherever needed 

• To participate in Quality improvement projects.  

 

Key responsibilities (In Points):

• Maintain and lead the activities for the planning and implementation of any analytical and / or process validation master plans for all MA’s held by the company. 

• Review and approve process validation protocols and reports for upcoming projects (Development / Technology Transfer / Product Lifecycle Management changes) and ensure SOP is followed throughout the process. 

• Perform detailed validation gap analysis of process and analytical method validations across the range of products under company portfolio as per relevant SOP. 

• Highlight any discrepancies / gaps identified in the existing validation, risk assess the identified gaps and propose and lead appropriate remediation activities by liaising with internal / external business partners to close the actions on time. 

• Support delivery of specific projects as Quality representative for site transfers, API dual sourcing, reformulation, and process improvements. 

• Based on Formulation / production experience, able to take decisions for any issues to be resolved during process validation batches, no. of batches to be taken based on product know-how and type of change. 

• Should be able to define CPP / CQAs based on formulation knowledge and accordingly review the process validation protocols and reports. 

• Should be able to review the analytical methods and method validation documents and perform the gap analysis against latest ICH guidelines and Pharmacopoeial requirements. 

• Maintain inventories for all existing process and analytical validation protocols and reports and ensure SOP is followed throughout the process. 

• Support change control process with impact analysis from validation perspective and suggest tasks as required. 

• Support QP’s; when required, in their batch release for reviewing key validation documents. 

• To ensure effective communication is maintained with internal customers & external manufacturers. 

• To review the existing procedures and do the necessary improvements needed in Validation Summary document process. 

• To provide the support in drafting the risk assessments for the issues logged in the risk register. 

• To provide the support in the preparation of monthly metrics and present on behalf of the team wherever needed 

• Provide support during inspection by competent authorities and / or during the customer audits. 

 

	Requirement	Essential	Desirable
Qualifications:
1	Bachelor’s degree in Pharmacy or Life Science	ü
2	Sound working knowledge of all Microsoft Office applications		ü
Experience & Competences:
1	Experience in pharmaceutical manufacturing or testing	ü
2	4 - 6 years of experience in an equivalent role (Formulation development / QA / Production / Regulatory CMC) within a pharmaceutical company handling the following:  Process validation  Analytical validation  Microbiological / Sterile process  Manufacturing of batches	ü
3	Has experience of working in a virtual company environment	ü
4	Knowledge of electronic document management systems and their use in a regulated environment	ü
5	Ability to work effectively as part of a team	ü
Knowledge & Skills:
1	Good knowledge of validation guidelines including ICH Q2 and Annex 15 of EU GMP Guide	ü
2	Competent use of grammatically correct written and spoken English	ü
3	Excellent communication skills, both oral and written, to include senior management in third party suppliers	ü
4	Knowledge of technical aspects of product manufacture including quality control and compliance	ü
5	Ability to check, analyze and investigate scientific data and information provided in the registered document	ü
6	Proactive nature with solution finding skills and abilities	ü
Personal Qualities:
1	Demonstrable attention to detail	ü
2	Logic and reasoning skills	ü
3	Proactive having organization and time management skills	ü