About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity - Head of QC
This position works out of Pakistan office in the Established Pharmaceutical division.
Established Pharmaceuticals - We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory
What You'll Do:
Quality Control & Excellence
• Oversee laboratory operations, including Incoming Materials (Raw & Pack), Finished Goods Testing, Stability and Microbiology Testing.
• Ensure adherence to established Abbott Quality Systems procedures and standards.
• Oversight the site stability program for New and Existing Products.
• Ensure the timely completion of Analytical Method Validation in compliance with Pharmacopoeia. Review and modify procedures as necessary, approving changes accordingly.
• Maintain analytical methodologies and instrumentation in a validated state.
• Evaluate and recommend all analytical equipment purchases through Lab CAPEX. Manage the Quality capital budget, including proposals, approvals, and equipment orders. Review and oversee laboratory supply purchases and consumables management.
• Serve as a key stakeholder for NPI projects and export market initiatives.
• Review and approve CTD documents related to Stability and QC for Product Registrations and renewals.
• Act as a key representative and decision-maker in the Analytical CoP for the manufacturing sites with other region(s).
• Be a permanent member of the Site Change Control Panel and lead the Site Inspection Readiness Team for QC lab.
• Coordinate and schedule Calibration / Maintenance for analytical equipment.
• Collaborate with Supply Chain and Production to achieve ADS, Supply Chain Plan and financial matrix for the site and region.
• Oversee IQ, OQ, and PQ processes for analytical equipment, ensuring documentation accuracy & fitness of document for purpose.
• Develop and maintain a training& coaching program for analytical staff and coordinate training sessions.
• Evaluate Laboratory OOS and Errors, execute technical investigations, providing CAPA to reduce errors.
• Ensure laboratory readiness year-round to meet Abbott’s internal and HA expectations.
• Act as the site analytical expert, engaging in cross-site and functional teams (e.g., Analytical Functional Group, CAP review group).
• Participate in internal and external audits, interacting with auditors (Divisional, AQR etc.), providing necessary documentation, and following up on action items.
• Develop and implement new technologies, identifying suitable options and researching applications.
• Review and track Raw Pack and Finished Goods using eLM tools.
• Establish and manage routine QC GEMBA tracking to ensure quality and safety compliance.
• Conduct regular reviews of Change Controls, CAPAs, and action items to ensure timely closure.
• Gap analyze compliance of all lab equipment with 21 CFR Part II requirements, ensuring timely audit trail reviews.
• Regularly attend S&OP and complete Lab related tasks.
• Any special project, assigned by Director QA.
Supplier Controls:
• Verify the qualification status of suppliers in Darius before releasing first consignment of each supplier.
• Manage all complaints related to suppliers.
• Participate in Supplier Quality Operations CoP, providing site-specific actions.
• Oversee supplier-related changes and actions.
• Assist in onboarding new suppliers through timely analyses, comparative studies, and stability evaluations.
• Continuously monitor and support local Pakistani suppliers through capability development programs.
• Ensure timely approvals for all raw and primary packaging material suppliers.
Support to Manufacturing Science & Technology (MS&T):
• Manage 100% testing for analytical test methods transfer and project related stability testing related to MS&T and Continuous Improvement Projects.
• Oversee all activities related to documentation of all new and existing product innovations under scope of MS&T.
Analytical Science & Technology (AS&T):
• Offer expertise in Laboratory Analytics to ensure analytical methods meet regulatory requirements and are suitable for their intended purposes.
• Work closely with Quality teams and laboratories to develop, validate, transfer, and maintain analytical methods while aiding in problem-solving.
• Act as the Analytical Subject Matter Expert (SME) for method transfers within the Supply Chain network.
• Lead troubleshooting efforts in the laboratory and guide internal analytical troubleshooting at Abbott as necessary.
• Ensure prompt implementation of Pharmacopeial updates.
• Apply proactive thinking to devise innovative solutions for complex technical challenges.
• Promote best practices for method harmonization and enhance organizational culture by turning ideas into action.
• Serve as the Analytical SME for health authority inquiries during regulatory discussions.
• Develop analytical strategies focused on continuous improvement, increased lab efficiency, and the adoption of advanced technical solutions across METAP CIS.
• Provide training on analytical topics to other departments.
• Contribute expertise to advance laboratory maturity and digitalization initiatives across METAP CIS.
EHS:
• Uphold and advocate for Abbott’s Environmental, Health, and Safety policies and procedures.
Internal / External Contacts:
Internal
• Product manufacturing operations, Commercial, and Planning
• Regulatory and NPI team members.
• QC Lab Managers in other regions
External:
• Instruments Vendors,
• Analytical TPT, MS &T
• Health Authority
Sensitive/ confidential data handled:
• Analytical data and documents needed for the release.
Key Areas of Accountability:
• Raw materials, Finished Product, Packaging material testing and release, Stability testing, market complaints, New Product/ Validation Testing.
Decisions made by this position:
• Take decision for the Release/ Rejection of the Raw Materials / Packaging Materials and finished Products.
Decisions contributed to:
• To provide support to QC lab, QA group, Validation Group, Stability Section, Packaging and MS&T
• Participate in the decision process of any function related to Quality of the product.
Decisions referred to next level:
• For the disposition for the Release/ Rejection of the Raw Materials/Packaging Materials and finished Products to DQA for final decision
Organogram: (Employee and his/her immediate Manager)
Job Specification
Knowledge & Experience:
• Knowledge of Documentation, Validation, Stability, technical problem resolution, and other all activities taking place in QC/QA.
• 10+ years of experience in relevant filed.
• B.Pharm
• Preferably Ph.D in Chemistry
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
In specific locations, the pay range may vary from the range posted.