AD-Quality Assurance

  Regulatory Affairs

Job title: AD-Quality Assurance

Company: Jubilant Pharmova Limited

Job description: Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiop

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly – owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it’s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL’s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer for more information about organization. Designation & Job : Associate Director Level : M1 Business Unit : Dosage Forms Function : Quality Assurance Country : India Work Location : Roorkee Reporting Manager : Senior Director & Site Quality Head Manager’s Manager : Head Pharma Quality Operations Matrix Manager : – Team Size : 05-10 Direct Reportees : 05-08 2. PURPOSE OF THE JOB Job Context: Determining, negotiating and agreeing on in-house quality procedures, standards and specifications. Assessing customer requirements and ensuring that these are met, setting customer service standards, specifying quality requirements of material, ensuring manufacturing standards comply with the standards, writing management and technical reports and customers’ charters, determining training needs, acting as a catalyst for change and improvement in performance and quality. Ensuring timely closure of investigations and come up with corrective action and preventive action Challenges: Facilitation of quality, collaboration, timely testing, maintenance of time-to-market of products, adequate and representative allocation of PAT sensor probes to ensure adequate sampling frequency 3. SCOPE & SIZE OF THE ROLE: (Please indicate key metrics defining the & scope of the role) Revenue / Operating Budget : Geographical Responsibilities : (Global/International/Country/Area within country) Roorkee Plant Area of Impact : (Dept. Location / Function or Business / Organisation) All departments 4. KEY ACCOUNTABILITIES Accountabilities Scope of work Quality System Management Responsible for review and authorization of design, implementation, monitoring of Quality system required for manufacturing and testing of pharmaceutical drug product as per cGMP Compliance Responsible for ensuring compliance of procedures related to cGMP followed for procurement, storage of starting material, processing and storage, testing of intermediaries and finished product. Responsible for ensuring compliance for various cGMP monitoring tools like internal Quality Audits / Self Inspection, in – process testing, line clearance etc. Compliance to GMP trends observations through self – inspections Representative Representative of site for QA systems during Regulatory inspections/external consultants’ visits/audits Finished Goods Responsible for approval or rejection of finished product Documentations Approval of all site quality related documents like SOPs, Validation Master Plan, Validation protocols, Validation reports, Equipment qualification documents, and site master file like to like Responsible for ensuring document control for designing, monitoring compliance of system for documents control – distribution, retrieval and archival of documents Change Controls Responsible for approval / rejection of all deviation, change controls, OOS, Investigation like Quality Procedure Market Complaints & Grievance Handling Responsible for handling market complaints, product recall as per laid down procedure Response to technical queries receiving from customers as well as regulatory guidelines Employees’ Training & Development Responsible for conducting cGMP training programmes and ensuring compliance to various trainings and training evaluations like SOP training, on job training, external training, unscheduled training etc. under the scope as per laid down procedure Recruiting / Staffing of quality assurance personnel and trainings of site personnel on quality concepts and regulatory guidelines CAPA Responsible for timely completion of investigations and decisive role for corrective and preventive action as per laid down procedure in consultation with Site Quality Head Ensuring the timely closure of critical quality events, adequate root cause, impact analysis, implementation and effectiveness of CAPAs Management of customer and regulatory inspection including responses and CAPA implementation within the time frame Technology Transfer Responsible for monitoring product technology transfer to site as per validation master plan Contract Laboratory Services Responsible for evaluation and subsequent approval or rejection of outside contract laboratory services, quality consultants, external agencies like to like in consultation with Site Quality Head. Quality Risk Management Responsible for Quality Risk Management lie risk assessment, communication, control and review of risk Quality Reports Accountable for products quality review reports (APQR) of all products manufactured Sample Testing Accountable for control of retention samples as per prescribed storage conditions which includes verification , disposal , abnormalities etc. Good Lab Practices Accountable for implementation of Good Laboratory Practices (GLP) in Quality Control Regulatory Guidelines Enforcement of regulatory guidance (including ICH , FDA, EU – GMP, TGA, WHO etc.) in the QMS 5. KEY INTERFACES External Interfaces Internal Interfaces Auditors Vendors Govt. official Regulatory Bodies Production Warehouse Quality Control Quality Assurance Technical Services 6. EDUCATION & EXPERIENCE Education Qualification (Highest) with target Institution(s) : M.Sc. / B.Pharm / M.Pharm Desired Certifications : – Experience Range : 12-15 years No. of years post Highest Qualification : 12-15 years Desirable Experience : 12-15 years of experience in solid dosage formulation unit 7. SKILLS REQUIRED Skills Description Proficiency Level () Functional Skills : Operating and trouble shooting skills on all major analytical equipments like HPLC, GC, UV, etc. Good Knowledge of Regulatory guidelines like MHRA, MCC, ANVISA, USFDA, TGA etc. Good knowledge of Quality Systems (eg. Market complaint handling, hangling of recalled or returned goods, OOS Investigations, deviations, Change Controls, Quality Management review etc. Behavioral Skills : Ability to motivate a team, recognize good talent and bring out the best of each individual Excellent communicator, influencing skills and negotiation skills to get management buy-in on ideas and concepts Self-motivated and enthusiastic Proactive, strong – minded, quick thinker and assertive Ability to handle conflict effectively General Awareness : Knows the fundamental or general understanding of concepts. Working Knowledge : Has broad job knowledge knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concepts in day to day practices. Functional Expert: Candidate is certified functional expert with strong knowledge on concepts. Mastery: Candidate is subject matter expert and has command over the subject/ concepts.

Expected salary:

Location: Roorkee, Uttarakhand

Job date: Fri, 04 Feb 2022 23:56:14 GMT

Apply for the job now!