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Senior Officer, Commstblylab-Arpl-Csa Ar

2 to 4 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: Minimum MSc / BPharm or equivalent degree. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Senior Officer, CommStblyLab-ARPL-CSA AR

Date Posted: August 11, 2025
Location: Bangalore, Karnataka, India, 560099
Company: Apotex / ApoPharma


Company Overview:

ApoPharma, a member of the Apotex group, focuses on discovering, developing, and delivering new medicines to improve the lives of patients suffering from debilitating and life-threatening diseases. Their major research includes investigating the role of iron in human disease and developing novel medicines for related conditions.


Job Summary:

Perform and report analyses of stability, in-process, finished products, and cleaning method validation using various analytical instruments.


Key Responsibilities:

  • Analyze stability, in-process, finished product samples, and cleaning method validation following prescribed methods and regulatory procedures.

  • Oversee all activities in the Quality Control Laboratory including cGLP adherence, documentation, and departmental quality system implementation.

  • Conduct timely analysis of in-process and finished product samples, prioritizing tasks as needed.

  • Perform all work in compliance with regulatory, safety, and quality requirements.

  • Coordinate with relevant departments on issues related to specifications, worksheets, and documentation to promptly resolve discrepancies.

  • Identify root causes of issues and recommend/implement corrective actions with management oversight.

  • Collaborate safely with team members to achieve desired outcomes.

  • Demonstrate organizational values: Collaboration, Courage, Perseverance, and Passion.

  • Ensure compliance with corporate programs including Global Business Ethics, Quality policies, Safety, Environment, and HR policies.

  • Perform other duties as assigned by the supervisor.


Education:

  • Minimum MSc / BPharm or equivalent degree.


Skills & Abilities:

  • Strong verbal and written communication skills with good interpersonal abilities.

  • Proficient in Microsoft Office (Word, Excel).

  • Ability to prioritize and plan work activities effectively to meet deadlines.


Experience:

  • Minimum 2 to 4 years of experience in a GMP-regulated pharmaceutical industry environment.


Equal Opportunity & Accessibility:

ApoPharma is committed to creating an inclusive and accessible workplace where all employees feel valued and supported. Accommodations are available for applicants with disabilities during the recruitment process. Please notify if accommodations are needed for interviews or assessments.