Job for M.Pharm, B.Pharm, M.Sc as Manager in External Manufacturing Quality at Apotex
Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.
Post : Manager- EMQ(External Manufacturing Quality)
• The Manager, External Quality is responsible for managing a portfolio of contract manufacturers supplying Apotex with finished products for the Americas region.
• The Manager is the primary point of contact on quality matters for the third party service provider and/or manufacturer within their portfolio, ensuring that products produced on behalf of Apotex are manufactured in accordance with cGMP, market regulatory requirements and meet our internal quality standards.
• The Manager acts as a representative of Apotex interacting and negotiating with high-level management of third party entities. The role entails developing relationships, negotiating issues and communicating Apotex quality requirements with third party service providers and manufacturers.
• There is significant interaction with numerous internal business units and external manufacturing organizations. Close collaboration is required on cross-functional teams comprised of members from Business Development, Co-Development, Commercial QA, R&D-QA, Regulatory Affairs, New Product Launch, Supply Chain, Legal and Sales & Marketing.
• Liaises with internal quality functions on quality issues relating to third party manufacture. Acts as the primary point of contact with third party organizations on all quality related matters.
• Participates in cross-functional new product introduction teams, ensuring quality and compliance are assured at launch and throughout commercialization. Acts as the point of contact for the transition from R&D Quality to Commercial Quality for co-development and in-licensed activities.
• Establishes a strong relationship with third party organizations. Implements quality systems to monitor key quality metrics to enable evaluation of trends and continuous assessment of compliance risks.
• Develops and negotiates quality agreements with third party organizations for new and existing third party operations involving Manufacturing/Packaging activities and all other activities, as required. Performs periodic reviews and ensures update of all current Quality Agreements.
• Receives and reviews impact of significant deviations generated by third party manufacturers and concurs action steps, as required. Initiates and drives through to resolution the Apotex ‘Critical Incident Management’ process for notification of significant quality incidents associated with third party operations.
• Reviews and approves third party manufacturer’s Stability, Process Validation and Analytical Validation protocols and Summary Reports, as required.
• Reviews and approves third party manufacturer’s Change Controls, as required.
• Provides oversight of third party manufacturer’s investigations into Customer Complaints, Quality Incidents and Deviations to ensure root causes are identified and effective CAPAs are developed and implemented.
• Reviews Annual Product Reviews issued by third party manufacturers, along with Apotex sections of responsibility, and ensures recommendations are implemented in a timely manner.
• Facilitates the Apotex External Audit process at key third party manufacturers. Defines appropriate action plans for improvement and periodically follows up and communicates action item closures.
• Follows up with Third Party Organizations to obtain current GMP evidence to support Regulatory Compliance status.
• Implements and applies a risk–based approach to third party manufacturing operations quality oversight and seeks efficiencies in operations without compromising product quality. Promotes continuous improvement activities.
• Contributes to the development and improvement of External Quality Operations while working as a member of the EQ team to achieve all outcomes.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory, compliance and safety requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.
• Graduate/Post Graduate in Lifesciences or Chemistry, Pharmacy or a related science is required.
Knowledge, Skills and Abilities
• Comprehensive knowledge of global cGMPs (HC, FDA and EU) and the Quality Management Systems associated with the manufacture of human drug products.
• Able to act independently, to take initiative and proactively seek resolution of quality issues in a timely manner.
• Excellent organizational skills, analytical thinking and inter-personal communication skills.
• Demonstrates personal leadership and accountability.
• Must be able to travel periodically, and occasionally at short notice, to visit clients and contract manufacturers within the region.
• Minimum of 10 years of experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably with multiple dosage forms, which would include a minimum of 3 years of applicable QA experience.
• Experience working in a sterile product manufacturing environment is preferred.
• Experience working with Biologics is preferred.
• Experience in managing day-to-day quality issues in a drug product manufacturing plant or with a contract manufacturer.
Qualification : B.Sc, M.Sc, M.Pharm, B.Pharm
Experience : 10 year
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : External Manufacturing Quality
End Date : 20th July, 2019
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