Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
Post : Assistant Manager, QA-APRL-QAIP AR
Job Summary
• To implement efficient, quality processes at ARPL in alignment with global standards that comply with heath authority requirements.
• IPQA activities, CCR initiation, Review, Approval, QA assessment, QA Responsible & final closure of CCR in QMS Track wise.
• SME for Swab/Rinse sampling, AQL, Cross contamination, MMaR’S / MPaR’S
• MMaR’S / MPaR’s Review & approval in live link.
Job Responsibilities
• Ensure adherence to GMP regulatory requirements by one and all in the facility.
• Planning & Co-ordination of daily activities in Manufacturing and Packing areas.
• Co-ordination & ensuring timely execution of in-process activities for manufacturing & packaging.
• Preparation and Review of SOP & Routine monitoring of all functional area to ensure adherence to the SOPs.
• Co-ordination of change controls, SAP Notifications, Deviations and SME for QAIP related deviations. & MMaR/MPaR block/unblock in SAP system.
• Performing QA assessment for SOP’S, Protocols, Master Manufacturing Records & Master Packing records and other GMP records.
• Initiation, Coordination for implementation of CAPA.
• Quiz Review in GLMS.
• In-process checks during manufacturing & packing stage, performance & Review of AQL, collection of samples as applicable and trending of AQL.
• Sampling of SLED batches Hold time study sample, In-process samples/Finished product samples
• Collection, storage and disposal of Reserve Sample.
• Review of executed batch records & log books. Co-ordination for Process validation & cleaning validation execution.
• To perform Swab/Rinse sampling for the cleaning verification & validation programme, cleaning & verification of sampling thief’s & accessories.
• Perform, Review & approval and co-ordination for in-house and external calibration.
• Review & approval of Master Manufacturing Records & Master Packing records in live link.
• Review and approval of Placebo and Submission batch documents.
• Line clearance of various in process stage such as dispensing, granulation, compression coating, sampling, primary packing and secondary packing etc.
• Preparation for internal, customers & regulatory audits and making the compliance for the same.
• Coordination for and performing gap assessment of Global Policies and Global SOPs.
• Coordination for internal, customers & regulatory audit compliance work.
• Preparation, Review & approval of Protocols and report.
• To maintain the Quality Risk Assessment for cross-contamination which includes initiating risk review activities, as required.
• Coordinate and manage Cross Contamination Control Program.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Responsible and accountable for competently managing subordinates and to provide all required training, equipment, tools and follow procedures in accordance with applicable regulatory & other pertinent requirements.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
Candidate Profile
• Bachelor of Pharmacy / Science or any equivalent degree.
Knowledge, Skills and Abilities :
• Should possess good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.
• SME for IPQA activities & Cross Contamination related activities.
• Imparting training & handling of team members (direct reports) with all compliance programs.
• Maintaining cross contamination related activities, Preparation and review of SOP.
• Live-link Track wise related to preparation and approval activities.
• Handling of Deviation, active participants for CAPA, Market complaints, LIR, Qualification related activities.\
• Minimum 10 Years of experience in GMP Regulated Pharmaceutical industry.
Additional Information
Experience : Minimum 10 Years of experience
Qualification : Bachelor of Pharmacy/ Science
Location : Bangalore, KA
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : QA-APRL-QAIP AR
End Date : Jan 25, 2023
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