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Assistant Manager Compliance - Jobs in Pakistan

1.00 to 10.00 Years   Pakistan   18 Apr, 2023
GSK plc
1 Jobs Openings
Job LocationPakistan
EducationNot Mentioned
SalaryNot Mentioned
IndustryOther Business Support Services
Functional AreaNot Mentioned

Job Description

Job Purpose This role supports the compliance activities to ensure that the sites products, processes, systems, facilities continuously meet current QMS, and regulatory requirementsThis role provide supports for Quality & Compliance by managing Internal and external audits, handling regulatory queries, provide oversight for effective record retention process and Quality Document System ˙Education & Experience B. Pharm, M. Pharm, Pharm D., M. Sc.Minimum 2 years of experience required in a similar domainKey ResponsibilitiesQMS Implementation:

  • Assess the applicability and extent of implementation of Global Quality Policy / Standards and Technical Standards
  • Manage effective integration of Quality Manual requirements into the local system by ensuring gap analysis, implementation assessments and action plans are established and progressed to completion
  • Approve completed Gap Analysis Templates/Implementation Assessment Tools including action plans
  • Assess the on-going effectiveness of Quality Management System implementation.
  • Act as a point of contact between the QMS Team and the site for effective communication of new or revised Global Quality Policy / Standards and Technical Standards requirements and for potential identified Quality Management System improvements
  • Review and improve the Quality Management System Implementation process
  • Progress report to Quality Council and regional Quality ? as per the requirement
  • Management of Quality Alert / Bulletin and Regulatory Intelligence
Record Retention:
  • Responsible for the compliance of record retention as per the requirement of Data & Document Management and Control process
  • Effective management of the Electronic Document control and Management System
Regulatory Compliance:
  • Timely responding queries from local regulatory authorities within stipulated time.
  • Provide technical information to regulatory affairs department as and when required.
  • To provide support on technical information to Legal and Corporate Affairs Department in case of any query from Ministry of Health (e.g., Mis-branded, Counterfeit, Spurious, Substandard etc.).
  • Provide the required support & documentation to the Company lawyer regarding the sealed samples when required.
  • Management of the Regulatory Sealed samples.
Auditing:
  • Perform and manage Internal Audits
  • Timely closure for CAPAs and actions from compliance related processes
Additional SkillsUse of MS-Office (Word, Excel, PowerPoint) at least to a moderate levelSound communication and presentation skillsDecision-making skillsGood capability to understand new official requirements and adopt to changesInfluencing skills, ability to manage conflict˙GSK is a global biopharma company with a special purpose ? to unite science, technology and talent to get ahead of disease together ? so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns ? as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it?s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We?re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.Contact information:You may apply for this position online by selecting the Apply now button.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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