Research Scientist - Stability Lab Apotex Corp.

3.0 - 7.0 years

0 Lacs

karnataka

On-site

About Apotex Inc. Apotex Inc. is a Canadian-based global health company dedicated to producing high-quality, affordable medicines for patients worldwide. With a workforce of almost 7,200 employees engaged in manufacturing, research and development, and commercial operations, Apotex medicines are available to patients in over 75 countries. The company's focus on generic, biosimilar, and specialty products is supported by vertical integration. Job Summary As a member of the ARD-Test Centre team, you will work under the guidance of a Supervisor or senior chemist. Your responsibilities will include conducting method validation for new products, performing full testing of API, in-process and finished dosages, and preparing regulatory submission documentation. You will also play a key role in project working teams. Job Responsibilities - Conduct validation of analytical testing procedures for drug substances and drug products. - Perform initial testing, stability sample testing, in-process testing, and raw material testing according to specifications. - Carry out additional tests required for dosage submissions. - Document and report results following established Standard Operating Procedures (SOPs). - Provide technical support to other departments in responding to deficiency letters from regulatory agencies. - Work collaboratively and safely as part of a team to achieve desired outcomes. - Exhibit behaviors aligned with organizational Values: Collaboration, Courage, Perseverance, and Passion. - Adhere to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, Health and Environment policies, and HR policies. - Collaborate with peers in R&D solid dosage to enhance expertise and address their needs. - Refer complex issues, along with recommendations, to the Supervisor. - Ensure all work is carried out in compliance with regulatory, compliance, and safety requirements. - Provide compliant advice to internal contacts and make complex decisions in alignment with regulations. - Perform any other relevant duties as assigned. Job Requirements Education: A graduate/postgraduate degree in Chemistry/Pharmacy from a recognized school/university. Knowledge, Skills, and Abilities: - Proficiency in wet chemistry, analytical bench techniques, and Window-based software. - Familiarity with automated data acquisition systems is advantageous. - Experience with Auto/Manual dissolution tests and GC is beneficial. - Strong written and verbal communication skills in English. Experience: BSc with 5 years or MSc with 3-4 years of experience in a pharmaceutical lab within an R&D environment. Apotex is dedicated to creating an inclusive and accessible work environment where all employees are valued, respected, and supported. Accommodations are available for applicants with disabilities during the recruitment process. If you require accommodation for an interview or testing, please inform us.,

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