Title: Specialist - Product Lifecycle
Position Summary:
The primary purpose of this job is to ensure that the cleaning processes used in pharmaceutical manufacturing are validated and compliant with regulatory standards. This includes validating the effectiveness of cleaning procedures for various dosage forms (oral solids, oral liquids, semi-solids, sterile injectables) to prevent cross-contamination and ensure product safety and quality.
Main Responsibilities:
- 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.
- Preparation and review of validation deliverables protocols and reports for the cleaning validation.
- Responsible for the calculation of MACO Value required for the cleaning validation. He/she shall be aware of the sampling technique adopted for the cleaning validation.
- Shall be able to do the risk assessment for the cleaning validation and able to identify the worst-case product.
- Involved in the cleaning Validation activities from the design stage up to the Validation completion activities.
- Shall be able to communicate with the cross functional team for the cleaning Validation activities.
- 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 3-5 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.