About this role
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