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Assistant Manager – Apipl-Psv Ap

6-10 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: M.Sc. / M. Pharma (Preferred) 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:

Assistant Manager – APIPL-PSV AP

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


Company Overview:

ApoPharma, a member of the Apotex group of companies, is dedicated to the discovery, development, and provision of innovative medicines aimed at improving the quality of life for patients with debilitating and life-threatening diseases. A key research focus is on the pathological role of iron in human diseases and developing novel treatments for such conditions.


Job Summary:

Coordinate with relevant departments to monitor, track, and ensure effective implementation and timely closure of Change Controls in the manufacturing process.


Key Responsibilities:

  • Review MBPCRs and MGCRs followed by change control impact assessment prior to approval.

  • Review executed BPCRs, GCRs, and manufacturing-related documentation.

  • Ensure manufacturing documents are properly issued and archived according to procedures aligned with manufacturing activities.

  • Monitor and ensure dispatch activities are initiated only after quality release.

  • Coordinate with the manufacturing team to resolve any quality issues arising during production.

  • Support investigation and resolution of deviations, including related Change Control activities.

  • Perform equipment and area clearance certifications for product changeover.

  • Handle SAP-related activities associated with quality and manufacturing.

  • Manage deviations and CAPAs related to manufacturing.

  • Prepare and review protocols and reports; monitor process and cleaning validation activities.

  • Prepare and review cleaning evaluation reports.

  • Prepare and review Annual Product Quality Review (APQR) documents.

  • Prepare and revise departmental SOPs, forms, and annexures.

  • Monitor cGMP compliance via plant rounds.

  • Adhere to EHS policies and procedures during routine activities and participate in EHS-related initiatives as needed.

  • Collaborate safely as a team member to achieve desired outcomes.

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

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

  • Perform any other duties as assigned.


Education:

  • M.Sc. / M. Pharma (Preferred)


Experience:

  • 6-10 years of experience with demonstrated skills in:

    • Preparation of protocols and reports

    • Monitoring process and cleaning validation activities

    • Handling change controls and deviations in GMP-regulated environments


Equal Opportunity & Accessibility:

ApoPharma is committed to fostering an inclusive, accessible work environment 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.