Sr. Specialist - Product Lifecycle

Position Summary:

The purpose of this job is to oversee and manage the validation activities critical to ensuring the quality and compliance of pharmaceutical manufacturing processes.

Main Responsibilities:

• Responsible for Process validation activities for the Oral Solid Dosage form, Oral Liquids, Semi-solids and Sterile Injectables.
• Involved in the strategy of new product launch and ensure that validation deliverables are well aligned with the management timeline.
• Responsible for the cleaning validation activities for the Oral Solid Dosage form, Oral Liquids, Semi-solids and Sterile Injectables. Shall be familiar with Sampling techniques and regulatory requirements (Holding time activities) in the cleaning Validation.
• Responsible for the Visual inspection Qualification process.
• Preparation and review of validation deliverables protocols and reports for the process validation, Visual inspection, gowning qualifications etc.
• Responsible for the Qualification of Facilities used in pharmaceutical companies.
• Responsible for the Aseptic Process simulation studies for sterile injectable plants.
• Responsible for the gowning Qualification process for sterile injectable plants.
• Responsible for the review of SOP and batch records based on the validation outcome.
• Work with area owner(s) to ensure the initiation and implementation of scheduled activities for the Qualification.
• Handling of Validation system related QMS like deviations, change controls and CAPA’s etc.
• Responsible for management for validation documents like archiving, retrieving and distribution.

Core Competency

• In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
• High compliance adherence, having strong diligence, initiative-taking, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Having a demonstrated skill in leadership and people management
• Motivated, organized, focused & overall compliance.
• Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
• Ability to understand new learnings and implant them in the workplace.

Qualification/Functional Knowledge

• Bachelor of pharmacy/Science with minimum work experience of 5-7 years.
• Well experience on SFDA, WHO, EU & USFDA audit exposure.
• Good Computer knowledge and knowledge of QMS system “Agile, Track wise, Amplelogic.”
• Proficient in English.
• Demonstrated solid experience in problem-solving and team management.
• Good Knowledge and command of cGMP
• Risk Assessment knowledge.