Cleaning Support Specialist

4 weeks ago

Delhi, India PSC Biotech Ltd Full time
Job DescriptionAbout PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

A fantastic career opportunity has arisen for a

Cleaning Support Specialist .

RequirementsBring energy, knowledge, innovation to carry out the following:

Responsible for issuing and management of cleaning changes and documentation.

Responsible for reviewing and incorporating relevant updates as communicated via the Technical Team Lead.

Responsible for management and tracking of Cleaning validation parameters and commitments.

Support for Cleaning Investigations

Compilation of CPV reports, CAR, and APRs

Ownership and management of changes.

Generation and tracking of cleaning campaign documentation.

Stewardship of validated campaign data.

Liaising with product teams to align turnaround targets.

Investigation support for Cleaning QNs.

Assessments of OOTs.

Support project assignments as required.

Completion of validation reports.

What skills you will need:

In order to excel in this role, you will more than likely have:

Degree qualification in a science or engineering-related discipline.

Knowledge of GMP standards.

Good communication skills, both written and verbal.

Strong technical writing skills.

Previous experience in API or Drug Product manufacturing is desirable.

To maintain accurate records in compliance with GMP expectations.

To understand and internalise procedures relevant to GMP operations.

To communicate clearly and concisely on technical issues.

To deliver project goals on time.

Demonstrated ability to work as part of a diverse team in an inclusive manner.

High personal integrity, credibility and energy.

Must be motivated and focused, with a demonstrated ability to be self-driven.

Communication - written, oral

#LI-KV1

RequirementsBring energy, knowledge, innovation to carry out the following: Responsible for issuing and management of cleaning changes and documentation. Responsible for reviewing and incorporating relevant updates as communicated via the Technical Team Lead. Responsible for management and tracking of Cleaning validation parameters and commitments. Support for Cleaning Investigations Compilation of CPV reports, CAR, and APRs Ownership and management of changes. Generation and tracking of cleaning campaign documentation. Stewardship of validated campaign data. Liaising with product teams to align turnaround targets. Investigation support for Cleaning QNs. Assessments of OOTs. Support project assignments as required. Completion of validation reports. What skills you will need: In order to excel in this role, you will more than likely have: Degree qualification in a science or engineering-related discipline. Knowledge of GMP standards. Good communication skills, both written and verbal. Strong technical writing skills. Previous experience in API or Drug Product manufacturing is desirable. To maintain accurate records in compliance with GMP expectations. To understand and internalise procedures relevant to GMP operations. To communicate clearly and concisely on technical issues. To deliver project goals on time. Demonstrated ability to work as part of a diverse team in an inclusive manner. High personal integrity, credibility and energy. Must be motivated and focused, with a demonstrated ability to be self-driven. Communication - written, oral

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