Job Title:
Senior Officer, Quality Assurance (ARPL-QAIP AR)
Date Posted: September 5, 2025
Location: Bangalore, Karnataka, India, 560099
Company: Apotex / ApoPharma
Company Overview:
ApoPharma, part of the Apotex group, is dedicated to discovering, developing, and providing new medicines to improve the quality of life for patients with serious and life-threatening diseases. A key research focus is on the role of iron in human disease and the development of novel medicines related to this.
Job Summary:
Perform In-Process Quality Assurance (IPQA) activities to ensure compliance and quality during manufacturing.
Key Responsibilities:
Conduct line clearance at various in-process stages such as dispensing, granulation, compression, coating, and sampling.
Monitor all functional areas routinely to ensure adherence to SOPs.
Prepare and review Standard Operating Procedures (SOPs).
Perform in-process checks during manufacturing.
Conduct Acceptable Quality Level (AQL) assessments, collect samples as applicable, and trend AQL data.
Sample SLED batches, hold time study samples, in-process, and finished product samples.
Manage collection, storage, and disposal of reserve samples.
Review executed batch records and logbooks.
Coordinate process validation and cleaning validation activities.
Prepare for and support internal, customer, and regulatory audits, ensuring compliance.
Perform swab and rinse sampling for cleaning verification and validation programs; maintain sampling tools and accessories.
Work collaboratively as part of a team to achieve organizational goals.
Promote a culture valuing trust, employee development, and growth, reflecting core values: Collaboration, Courage, Perseverance, and Passion.
Perform additional duties as assigned.
Education:
Bachelor’s degree in Pharmacy, Science, or an equivalent field.
Skills & Abilities:
Strong communication and interpersonal skills.
Proficient with MS Office and internet applications.
Experience in preparation and review of protocols and reports.
Experience:
Minimum 2 years in a GMP-regulated pharmaceutical industry.
Equal Opportunity & Accessibility:
ApoPharma is committed to fostering an inclusive and accessible work environment. Accommodations are available for applicants with disabilities during the recruitment process. Applicants should notify if accommodations are needed for interviews or assessments.
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