QC Specialist (CSV / Equipment Qualification) (1 year contract) | Pharma | Tuas

GMP Group; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A prominent recruitment firm in Singapore is seeking a qualified individual to lead the analytical equipment qualification for new and existing technologies. The role requires a degree in Pharmaceutical Sciences or related fields and at least 2-3 years of relevant experience in the pharmaceutical industry. The candidate should have strong knowledge of compliance regulations and good communication skills. The company offers a supportive environment for professionals looking to enhance their careers.

Qualifications

• Minimum 2-3 years of relevant working experience in the Pharmaceutical Industry.
• Experience in analytical equipment qualification including computer system validation.
• Knowledge of operation of analytical equipment and QC testing will be an advantage.

Responsibilities

• Leads analytical equipment qualification for new equipment and technology introduction.
• Ensures timely implementation of projects with compliance to regulations.
• Collaborates with stakeholders on qualification processes.
• Writes change controls, events, deviations, CAPAs, and GMP documents.

Skills

Analytical equipment qualification

Good communication skills

Ability to work independently

Knowledge of cGLP & cGMP

Knowledge of compendia and regulatory requirements

Education

Degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Biotechnology, Engineering

Job description

Leads equipment qualification for new/existing analytical equipment and supports the transition of the knowledge to local QC unit for lifecycle management.

Jobscope:

• Leads analytical equipment qualification for new equipment / technology introduction.
• Ensures timely implementation of the projects with full compliance to corporate, regulatory and external agency regulations if applicable.
• Collaborates closely with local and global stakeholders on new equipment / technology introduction and qualification.
• Writes change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports).
• Ensures spendings are within project target budget.

Requirements:

• Degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Biotechnology, Engineering, or related discipline.
• Min. 2-3 years of relevant working experience in the Pharmaceutical Industry
• Experience in analytical equipment qualification (including computer system validation for analytical equipment
• Knowledge of the operation of analytical equipment will be an advantage
• Experience in QC testing will be an advantage
• Knowledge of cGLP & cGMP
• Knowledge of compendia and regulatory requirements
• Good communication skills and ability to work independently in a highly regulated manufacturing environment.

To find out more about this opportunity, please contact Fiona Koh; [e-mail]

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239

This is in partnership with the Employment and Employability Institute Pte Ltd (e2i).

e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives.

By applying for this role, you consent to GMP Recruitment Services (S) Pte Ltds PDPA and e2is PDPA