Senior QA Specialist

AstraZeneca•Canóvanas, PR

33d

About The Position

This position is responsible for all QA activities that directly support execution of the process, both within the PET and in assigned areas outside the PET, ensuring compliance. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, investigations, SOPs, supplier management and regulatory interactions. At the Senior Level the incumbent will be trained and demonstrate some level of proficiency in all of the major responsibilities of the role. The incumbent must demonstrate a strong understanding of the area to which the individual is aligned. The incumbent will act as execution lead/process owner for one or more processes.

Requirements

Bachelor’s degree in a Sciences / Technical field such as Pharmacy, Biology, Chemistry or Engineering and at least seven (7) years related experience in the pharmaceutical industry with emphasis in Quality or Compliance position; or, equivalent combination of education and experience.
Fully Bilingual (English & Spanish)
Advance knowledge of Microsoft Office applications (i.e., Word, Excel, Project, Power Point, Outlook) or similar computer applications.
Advance knowledge of databases/application systems (i.e., SAP, Global LIMS, Documentum, Saba, TrackWise, Change Controls, Complaints).
Up to date knowledge of cGMP regulations and end-to-end supply chain management principles. Knowledge of pharmaceutical operations processes: warehouse, manufacturing, packaging, laboratory, in process, etc.
Strong ability and motivation to learn.
Capable of making timely decisions with facts on hand, even when under pressure.
Good communication across all levels or the organization and capable of building and maintaining open lines of communication.
Strategic and tactical customer stakeholder management.
Understanding of statistical data and capable of drawing or reaching conclusions from supporting data concepts (i.e. normal distribution, percentages, ratios and proportions to practical situations).
Ability to read, analyze and interpret common scientific and technical journals, financial reports and technical documents.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Monitors own work to ensure quality. Meets productivity standards. Completes work in timely manner. Strives to increase productivity.
Demonstrates accuracy and thoroughness.
Looks for ways to improve and promote quality. Applies feedback to improve performance.
Displays willingness to make decisions. Exhibits sound and accurate judgment.
Knowledge in ANSI/ASQ Z1.4 Standard and auditing of documents for GMP compliance.
Business acumen focused on ensuring continuity of supply, cost-savings and reducing non-value adding activities.
Balances team and individual responsibilities. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Supports everyone's efforts to succeed.
Ability to solve practical problems and deal with variables in situations where only limited standardization exists.

Nice To Haves

Licensed chemist or registered pharmacist (desirable)

Responsibilities

Escalate to QA management (i.e., QA Manager /QA Compliance Operations Manager or Head of Quality) any discrepancies (potential or real) during daily operations.
Provide expert advice on Good Manufacturing Practice/Good Development Practice/ Good Laboratory Practice to Operations and ensure compliance with the associated quality standards.
Review, evaluate and/or approve minor investigations from Manufacturing Teams and Support Areas.
Support major and critical site investigations. Conduct QA area investigations.
Support local complaint investigations, identify and rectify any trends.
Perform product release activities and recommend batch disposition.
Collate the required documentation for product quality reviews within the required timescales.
Ensure compliance with change management processes within the Process Execution Team (PET) and approval of associated documentation at a local level.
Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgments, within general operating guidelines.
Look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
Produce and deliver Good Manufacturing Practice training within the Process Execution Team.
Identify QA enhancement opportunities, and actively participate and coordinate with QA Management the required activities to implement these opportunities.
Ensure plant readiness for any regulatory inspections including periodic walkthroughs.
Execute and/or support local audits (both internal and external) to aid in developing follow up improvement plans to ensure ongoing compliance.
Review and approve documentation generated as a result of experimentation, validation, new product technology introduction (i.e., Experimental Programs and Reports, Process and Cleaning Validation, Release Requirements Determination, Computer Validation Lifecycle documents, Risk Assessment for Qualification purposes, Installation Qualification, Operation Qualification, Technical Projects, Applications Change Controls, and CMC regulatory submission modules, among others).
Review and approve Master Production Document (MPD's), SOP's, Field Change Notifications, Change Controls, Material Specifications, CAPAs, Minor complaints, Minor deviations and other GMP related documents within the Manufacturing Teams and Support areas.
Prepare or review QA agreements and contracts for partner AZ sites, contract manufacturers, laboratories, vendors, and suppliers.
Generate and/or revise GMP and regulatory CMC documents to ensure compliance with regulations, company procedures and/or standards, and regulatory commitments.
Support and maintain the Vendor Certification Program, Change Control, Regulatory CMC, Investigation System, and other compliance and quality systems.
Support development and implementation of systems or CAPAs identified during audits, regulatory inspection, and pre or post-approval negotiation.
Participate in the development and implementation of Quality Risk Assessments (QRA).
Participate in project teams created towards problem solving or specific issues, to ensure GMP and regulatory compliance.
Participate in the management and decision-making process of quality and regulatory compliance issues related to process, facilities and systems, and day-to-day activities that could impact the supply chain routine manufacture, startups, validation, and qualification activities.
Coordinate and support the interdepartmental revision of documents to be submitted to the regulatory authorities. Liaise with AZ RA and CMC RC to resolve submission problem areas or queries received from the health authorities.
Coordinate with the regulatory agencies and IPR personnel all the necessary information and requirements for renewing the Company regulatory licenses, as required.
Coordinate with the corresponding iPR and CMC RC representatives, PRHD, PR US Department of State, US Department of State, and the appropriate Embassies and Consulates, the preparation, modification, notarization, and legalization of documents for registering IPR products into or renewing CMC manufacturing licenses in the European and Rest of the World (RoW) markets (Registration Documentation).
Train and mentor junior members of the QA organization and providing QA coaching to other non-QA employees within the area supported.