Title: 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.