Specialist, Validation

Advanz Pharma -
Mumbai, Maharashtra

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Job details

10 days ago

Qualifications

English
Microsoft Office
Bachelor's degree
Quality control
Pharmacy
APIs
Manufacturing
Document management systems
Communication skills
Time management

Full job description

Date: 16 Jun 2026

Location: Mumbai, India

Company: AdvanzPharma

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:

Bachelor’s degree in Pharmacy or Life Science

Sound working knowledge of all Microsoft Office applications

Experience & Competences:

Experience in pharmaceutical manufacturing or testing

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

Has experience of working in a virtual company environment

Knowledge of electronic document management systems and their use in a regulated environment

Ability to work effectively as part of a team

Knowledge & Skills:

Good knowledge of validation guidelines including ICH Q2 and Annex 15 of EU GMP Guide

Competent use of grammatically correct written and spoken English

Excellent communication skills, both oral and written, to include senior management in third party suppliers

Knowledge of technical aspects of product manufacture including quality control and compliance

Ability to check, analyze and investigate scientific data and information provided in the registered document

Proactive nature with solution finding skills and abilities

Personal Qualities:

Demonstrable attention to detail

Logic and reasoning skills

Proactive having organization and time management skills

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