Executive, Analytical Method Validation (AMV)

NOVUGEN PHARMA (MALAYSIA) SDN. BHD.; Nilai; In loco; MYR 72.000 - 98.000; Tempo pieno

Descrizione del lavoro

Novugen Pharma (Malaysia) Sdn. Bhd. in Negeri Sembilan seeks an Executive, Analytical Method Validation to support AMV development, validation and tech transfer for formulations. The role includes preparing dossiers and ensuring compliance with regulatory standards.

You will perform validation activities for assay, dissolution, related substances; maintain documentation, manage instruments, and coordinate with cross-functional teams under supervision.

Competenze

• Degree in a relevant pharmaceutical discipline.
• Minimum 3 years’ experience in pharma/healthcare industries.
• Experience in Analytical Method Development & Validation technologies.
• Proficient in analytical techniques (HPLC, GC, UV-Vis, dissolution testing).
• Knowledge of regulatory expectations for analytical submissions and data integrity.

Mansioni

• Shall perform method validation, verification and method transfer of analytical methods.
• Shall prepare protocol and report for analytical method validation, verification and technology transfer.
• Shall execute assay, dissolution, related substances and other physico-chemical tests for drugs.
• Shall qualify or prepare working standards as per the requirement.
• Online documentation of raw data, logbooks and calibrations; ensure SOPs and GLP compliance.
• Maintain chemicals, HPLC/GC columns, reference standards and working standards per SOP.
• Maintain instruments and calibrations/performance verifications per schedules.
• Coordinate with functions to fulfil analytical prerequisites for API and finished product AMV.
• Assist in preparing and reviewing risk assessments and ensure timely approvals.

Conoscenze

Analytical Method Development

Method validation

HPLC

GC

Dissolution testing

ICH/GxP knowledge

Formazione

Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or equivalent

Descrizione del lavoro

Executive, Analytical Method Validation (AMV)

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

About the role

The Executive, Analytical (AMV) is responsible for supporting analytical method development, method validation, and analytical support for formulation development and technology transfer. This includes conducting various testing activities, preparing dossier documentation, and ensuring adherence to regulatory and company standards.

Key Responsibilities

• Shall perform method validation, verification and method transfer of analytical methods.
• Shall prepare protocol and report for analytical method validation, verification and technology transfer etc.
• Shall execute Assay, Dissolution, related substance and other Physico chemical tests validation for drug substance and drug products.
• Shall qualify or prepare working standards as per the requirement.
• Online documentation of raw data, entries of logbooks and system calibrations in time, ensure compliance to SOPs, GLP and Good documentation practices.
• Maintain the management of chemicals, HPLC and GC Column, reference standard and working standard as per the SOP.
• Maintain instruments and the respective calibrations / performance verifications as per defined schedules.
• Manage all AMV documents in well-organized manner and always make sure all documents are readily and easily retrievable whenever requested.
• Coordinate with functions to fulfil analytical prerequisites for API and FP AMV execution under manager's supervision.
• Assist in preparing and reviewing risk assessments (e.g., nitrosamines, elemental impurities) and ensure timely approval as guided.
• Should be flexible to align self-plan with dynamic timelines and project’s need.
• Ensuring good relation and communication with all members of the internal and external teams.
• Shall be flexible to align plan with dynamic timelines and project’s need.
• Shall maintain good laboratory practices as per Novugen guidelines.
• Shall follow data integrity policies strictly to maintain the compliance.
• Shall undergo or complete necessary GXP trainings as per the schedule.
• Shall complete the necessary SOP trainings mandatorily.
• Ensuring lab cleanliness and personal safety and lab safety.

About you

• Must possess a Degree in Pharmacy, Pharmaceutical Sciences, Chemistry or equivalent.
• 3 years related experience in Pharma, FMCG, and Healthcare industries.
• Experience in Analytical Method Development & Validation technologies.
• Proficient in analytical techniques such as HPLC, GC, UV-Vis spectroscopy, and dissolution testing
• Knowledge of regulatory expectations for analytical submissions and data integrity.
• Good understanding of GLP, GxP, ICH, and related international regulatory standards
• Strong industry-academia fraternity and business acumen to promote new technologies.
• Strong intrapreneurial skills and mindset from start up to established organization.
• Proficient in Microsoft office Suite
• Proficient in using software/tools relevant to the pharmaceutical or healthcare industry etc