Ensure that a quality management system is implemented and maintained in the local market, including:
Acts as the local quality responsible person for gdp in accordance with market regulatory requirements
Maintains quality system documentation: procedures and records
Bms policy/directives/sops impact assessment and implementation
Gdp and local regulations impact assessment and implementation (manage the process of assessment for the new directives -regulatory surveillance-
Maintain up to date quality manual for bms india.
Ensures initial and continuous gmp/gdp training programs are implemented and maintained, including product identification and avoidance of falsified medicine
Ensures that relevant customer complaints are dealt with effectively
Manage and oversee the process for product quality complaints across the mea&i region
Manage and oversee the processes for deviation, capa and change control management
Performs periodic self-inspections according with the self-inspection plan and puts in place necessary corrective measures
Ensures reviews of the apqrs, as required per local regulations
Leads the quality management review/quality council of the market
Ensures reporting of quality metrics and implements adequate action plans for metrics achievement when necessary
Supplier management oversight: quality agreements, approving any local subcontracted activity which may impacts product quality, evaluate, and confirm the overview of the supplier qualification status across the mea&i region.
Be the custodian of approved suppliers list (global/local) of all gxp vendors
Customer oversight: periodic customer license verification
Product quality status and batch release or approval to the market at dc including (on hold products request, & promptly perform any market action operation, recall, for products.)
Analytical transfer coordination/approval to meet product launch, when applicable
Handling compliance/quality events with the impacted market team
Attendance to the market action meetings when required
Conduct mock recalls locally with the help of internal and external stakeholders
Oversight the return process, according to bms requirements
Quality input on shortage situations and oversight reporting to health authority
Medical samples quality distribution oversight.
Driving improvement opportunities in the areas of regulatory compliance, quality performance metrics, agility, responsiveness, customer / consumer centric activities.
Facilitate that bms requirements are implemented in the local distribution centre for: warehousing (including storage) facilities, secondary packaging facilities transportation & distribution processes
Support the global quality audits in the market
Ensure readiness for ha inspection in local entity and leading ha inspection
Works autonomously as agreed on the accomplishing defined goals and objectives
Participate in operational activities for middle east & africa (mea) quality as required
Formal delegate / back up of mea qrp
Expected area of competence:
Implementation and maintenance of quality management system, for the distribution activities with bms product in india
Escalate by communicating quality issues and decisions, which impact the business.
Ensures compliance of market third party distribution partners to bms quality requirements related to distribution and transportation.
Identify continuous improvement activities for more effective quality systems across the organization.
Participation to company business growth objectives for quality alignment.
List of minimum requirements and required competencies
Must possess a bachelor`s degree in sciences, preferably in pharmacy
Minimum of 5 – 7 years of progressive experience within the quality function of the pharmaceutical health care industry or with regulatory agencies
Knowledge and experience in pharmaceutical health care operations, quality control, quality assurance & compliance, distribution and international regulations are essential.
Proficient in gdps and regulations promulgated by the fda, ema or equivalent regulatory agencies, and requirements for pharmaceutical products distribution.
Ability to develop and apply bms operating philosophy and to operate within company policies and procedures within quality and compliance area.
Good verbal, written and presentation skills in english, to deal effectively with all levels of management.
Strong working knowledge in pcs (experienced in excel, word, powerpoint and sap) and in quality systems
Team oriented worker with excellent interpersonal skills.
Ability to switch prioritiesAbility to conduct in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
Ability to collaborate and communicate directly to cross functional and cross regional teams.
Negotiating skills for interfacing with health authorities and market business functions.
Ability to effectively communicate ideas to others to accomplish challenging goals and objectives
Demonstrates our bms values:
Integrity / innovation / urgency / passion / accountability / inclusion
Around the world, we are passionate about making an impact on the lives of patients with serious diseasesEmpowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol myers squibb recognizes the importance of balance and flexibility in our work environmentWe offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Posted 6 days ago