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| Job Location | Baddi |
| Education | Not Mentioned |
| Salary | Rs 7 - 10 Lakh/Yr |
| Industry | harma / Biotech |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
To lead and manage the strategic and operational performance of the Quality department, ensuring the successful delivery of business objectives, whilst adhering to regulatory compliance and achieving business success.Designation & Job : Head - QualityWork Location : Baddi, Himachal3. KEY ACCOUNTABILITIES:Accountabilities:-Establishment and Implementation of Quality SystemsDeveloping and implementing Quality departments strategy, to ensure it meets business requirements.Ensuring development of departmental SOPs in accordance with all Compliances.Monitoring implementation of all systems to ensure all activities are performed in accordance with GMP, and other regulatory requirements - to ensure 100% customer satisfaction.Design quality systems/SOPs to support external Mfg activities.Strengthening GLP in R&D I, II & IV and establishment of Quality systems for cGMP area in R&D IV.Audit, Compliance & ApprovalLeading customer and regulatory audits/inspections, as required.o US-FDA, MHRA, ANVISA and other countries regulatory audit/compliance & approval of the regulated plant.Acting as the main point of contact on all Quality matters with external agencies.Maintaining and improving departmental operational performance, to meet the quality requirements of regulatory authorities, company SOPs and external and internal Customers.. To ensure the efficient and effective day to day running of the department.Ensuring appropriate investigation of discrepancies, errors, complaints, failures, in case any.Training & DevelopmentFacilitate training to ensure development of all the employees on knowledge & understanding of documentationCAPAcGMP conceptsRA guidelines etc.Strengthen & drive the culture of quality at manufacturing units & R&D by training & other interventions.Managing, motivating, coaching and mentoring teams, to higher levels of management capability.Planning and Budgeting for qualityPreparing and justifying the Quality departments budget.4. KEY INTERFACES :External InterfacesRegulatory & other Govt. agencies (both national & international)Internal InterfacesManufacturing, R&D, Regulatory Departments5. EDUCATION & EXPERIENCE :Education Qualification(Highest ):- M.Sc (Chemistry) / M.Pharm / Ph.D /B.PharmaExperience Range : 15 to 22 YearsDesirable experience : Pharma Industry Experience6. SKILLS REQUIRED:Functional Skills:-Strategic thinkingStrong analytical and problem solving ability.Excellent attention to detailExcellent hold on Regulatory StandardsBehavioral Skills:-Strong leadership/team management skillsStrong Communication & Interpersonal SkillsAbility to persuade
Keyskills :
assurancedeliveryqualityengineeringcompliancemanagementtestingegulatorycontrol