Total 2 job vacancies by Integrity Partners Pte. Ltd.

Overview

Company: Consumer Healthcare MNC

Position: Regulatory Operations Associate

Contract: 1-Year

Key Responsibilities

1. Provide support in change control, process improvement and new initiatives implementation.
2. Provide support in regulatory submission document compilations
3. Support CMC-related projects and regulatory operational activities.
4. Take part in data migration and data integrity project, enduring data accurary and reliability while providing inputs for gap analysis and corrective plans as appropriate.
5. Maintainence of regulatory database and system.

Requirements

• Bachelor’s Degree or Diploma in life sciences or related field.
• 6 months to 1 year expeperience (including internship), in a technical or scientific role in a pharmaceutical company is advantageous.
• Proactive, able to work effecitively independently and as part of a team in a fast-paced environment.
• Strong communication skills to collaborate with both internal and external stakeholders.
• Demonstrate ability to handle multiple project with strong organizational, planning and follow-up skills

Interested Applicants

• Please apply with your updated CV. Suitable candidates will be contacted for a confidential discussion regarding this exciting opportunity.

We appreciate each application of interest for this position. As we carefully review and consider each application in our thorough selection process, we regret to inform that we will be reaching out only to shortlisted candidates for discussion.

Not the right opportunity?

We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

My client a well established Pharma company is looking out for a competent QA Associate, this following are the requirements:

Responsibilities

• Contract/External Manufacturer Quality Oversight: Monitor quality aspects of contract manufacturers, including handling OOS/NCR/Deviation and CAPA, Change Control, and routine stability testing. Ensure compliance with GMP and relevant standards, meeting timelines for actions.
• Releases of products : Oversee batch release to prevent recalls or critical quality issues in the market.
• Change Control: Address individual change controls promptly and efficiently. Manage the change control process, ensuring compliance with GMP and company SOPs. Execute change control tasks within defined timeframes.
• Artwork Review: Conduct artwork reviews to meet requirements.
• Manage deviations, NCR, CAPA: Prevent recalls or critical quality issues related to due diligence.
• Customer Complaints: Collaborate with internal departments and suppliers to oversee the complaints process.
• Document Management:Update SOPs/WIs/FGS as per role responsibilities.
• Internal and External Auditing: Conduct and faciliate resolution audits within specified timeframes, adhering to regulations and SOP and follow up on NCR/CAPA outcomes.

Key Requirements

• Possesses BSc in chemistry, pharmacy, or related field.
• 1 to 3 years of QA experience in pharmaceutical/medical device industry
• Strong familiarity with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
• Experience in supply chain quality, manufacturing quality, or quality management in commercial settings.
• Proficient in deviation management, CAPA, change control, and documentation within pharmaceutical/medical device sectors.
• Auditing experience is desirable.
• High level of attention to details

How to Apply:

Interested applicants may apply by sending in your updated résumé (in MS Word format) to my email or apply directly:

Consultant: Tan Jun Jie

EA personnel reg. no.R1878852

EA License No. 17C8502