Compliance Manager - Singapore - NUSANTARA PRIME CONSULTING PTE LTD

NUSANTARA PRIME CONSULTING PTE LTD

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

beBee Recruiter

Description

Responsibilities:

Provide strategic direction and advice to project team regarding regulatory pathways and timelines for new and

changed products/processes.

Oversee QA Compliance and Audit related activities to ensure safe, efficacious and quality products can be

supplied in accordance to regulatory and business requirements.

Work within the Regional QA organization to provide support and guidance regarding document management, training,

metrics and management review ensuring compliance with regulations and site Quality System requirements

Manage onsite audits and quality questionnaires, related to Suppliers and Third-Party Manufacturers
Serve as single point of contact for the regions for QA Project Management
Ensure that qualityrelated projects associated with manufacturing plants conform to current cGxP as well as project plan,

its requirements and risk assessment

Manage product and process quality and compliance throughout the life cycle from development to commercialization.
Primary QA interface for technology transfers & New Products introduction
This role provides leadership in finalizing and maintaining the regional quality and validation strategy
Collaborates with Operations, other Quality team, Engineering functions
Quality Audit (Internal & external): Manage all activities related to onsite GxP audit Suppliers and Third party

Manufacturers including Affiliates in line with divisional, filing and regional SOP requirements. Prepare, maintain a
and execute Audit Schedules and ensure their compliance

Take ownership to continuously simply processes

Requirements:

Bachelor's Degree in Pharmacy / Life Sciences / Chemistry / Microbiology / Engineering or other technical / scientific disciplines
Minimum 5 years of combined experience in QA, Operation or Technical Function in pharmaceutical industry with proven

leadership skills

Knowledge of relevant regulations for quality systems and compliance.
Extensive knowledge of worldwide GLP / GMP regulatory requirements and industry best practices.
Manufacturing or Quality related experience in some of the following areas : sterile, liquid, solids or API's.
Knowledge and experience with Sterile and Non-Sterile process is a must.
Ability to use Quality Risk Assessment and Root Cause Analysis tools
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
Detailed knowledge of inspection and auditing standards
Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy

corporate, regional, and local objectives.

Must be able to effectively deal with problems and internal customers.
Good understanding of SOPs, GMPs and quality systems (e.g. ISO, Auditing).
Understanding of cultural practices and cultural expectations within relevant markets in the region is necessary.

To have worked in a multicultural environment is highly desirable.