Quality Assurance Director/ Директор по обеспечению качестваApply Now Email Me Job ID R0015944 Date posted 01/14/2020 Location: Moscow, Russia
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Manage GxP-regulated activities to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner
Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures. These include but are not limited to: change control, deviation, CAPA management, training, document management, complaint handling, etc.
Implement Supplier Quality Program using a lifecycle management approach.
Establish and maintain internal and external Quality Agreements.
Ensure new GxP-suppliers/ contractors are audited and qualified before use. Lead or participate in quality audits, & support QA due diligence of new business partners.
Provide quality oversight of local GMP/GDP activities, e.g. local (re)labelling/(re)packaging, cold chain management, temperature excursion management, method transfers, etc.
Perform batch releases &/or duty of care releases, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
Review PQRs to ensure acceptability to the requirements of the market
Establish and lead internal audit / self-assessment program, to evaluate compliance with product quality systems & processes, and to identify improvement opportunities.
Lead regulatory inspections for GMP/GDP/Product quality related activities, and ensure that regulatory commitments are duly completed on time.
Develop and execute Annual Country Quality Plan. This will include the following:
- Establish and maintain the local risk register. Engage the key stakeholders to proactively identify GMP/quality risk areas, and establish appropriate risk mitigations and risk monitoring program.
Ensure local Quality Council / Management Review is conducted on a regular basis.
- Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions.
Main point of contact for the investigations and resolution of all product quality issues discovered or originating in the LOC and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, BU) and GMS on such issues.
Management of product-related complaints, and quality investigations at the LOC. Report suspect counterfeit cases and support GPP investigations.
- Drive timely implementation of CAPAs where required, and verify CAPA effectiveness
Initiate Notification to Management / escalation report for notifiable events in accordance with Takeda Global Procedure.
- Execute local recall/market action once the decision is endorsed by Market Action Committee (MAC), and ensure timely completion of the required actions.
Lead, or support health authority communications on Product Quality issues impacting the country
Lead the implementation of GxP-enterprise system(s), ensuring that CSV and data integrity requirements are met.
Drive and strengthen the Quality Culture.
Gather local regulatory & quality intelligence. To communicate and raise awareness of upcoming and new regulations within Takeda.
Provide quality support for product launches.
Perform customer bona fide checks, to ensure the appropriate & valid authorizations and licenses are in-place.
University degree in Pharmaceutical Science, Pharmaceutical Technology, Microbiology, Chemistry or equivalent
Minimum of 5-7 years in a QA/QC position in Pharmaceutical industry
Possesses appropriate quality and technical experience, and RP qualifications (latter as required under local regulations)
Prior experience managing external GMP/GDP suppliers
Ability to make sound and effective quality decisions under pressure
Skilled at leading GMP/GDP audits
Able to work independently
Fluent in written and spoken English
Strong cGMP knowledge and experience
Familiarity with local and international GMP / GDP regulations
Critical Thinking skills
dept in leading investigation and problem-solving
Strong communication and stakeholder management skills.
Competitive salary and bonus system
Medical and life insurance
Unlimited opportunities for professional self-realization
Empowering Our People to Shine