Nourish Pharmaceutical Pvt. Ltd. is a pharmaceutical formulation manufacturing, specializes in manufacturing Tablets, Capsules & Oral Liquids Finish Products.
- Vacancy details:
- Department: Quality Assurance Manager
- Qualification: B.Pharma, M.Pharma
- Experience:6 – 10 years
Greetings from Nourish Pharmaceutical Pvt. Ltd…!!!!
Important Details :
- Location:Dholka, Ahmedabad, Vadodara
- Post of date:09/09/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: face to face
- Interview Rounds of Interview: HR
Walkin Interview Details:
Date:11th September – 20th September
Time: 10.00 AM – 5.30 PM
Venue: Nourish Pharmaceutical Pvt. Ltd. Plot No: 72 to 74, Kheda Industrial & Logistics Park, Kheda – Dholka Highway, Vasna Bujarg, Kheda 387560, Gujarat, India (View on map)
Job description
Roles and Responsibilities:
1. Develop and implement quality assurance policies and procedures to ensure cGMP compliance with regulatory requirements, such as those from the FDA and EMA, in the plant.
2. Engage in strategic planning and execution of the Quality Management System to maintain high-quality standards and adhere to cGMP guidelines in the manufacturing process of pharmaceutical oral solid dosage forms.
3. Conduct and lead internal and external audits, and self-inspections by regulatory agencies, and internal/external auditors.
Team Management
4. Accountable for maintaining discipline in the Quality Assurance department by ensuring compliance with established policies, procedures, and standards, while promoting a culture of professionalism and efficiency.
5. Accountable for overseeing the planning, scheduling, and distribution of document preparation workflows for the Quality Assurance department, ensuring timely task completion and interdepartmental coordination to enhance operational efficiency.
6. Accountable for allocating tasks to Quality Assurance professionals using Microsoft tools, email, or verbal communication, supervising team workflow, and regularly updating progress to top management.
7. Accountable for guiding and training QA professionals to develop specialized expertise, evaluating skills, and reviewing training reports to ensure they are well-prepared and qualified for their respective roles within the department.
Document Management
8. Ensure the thorough review, meticulous approval, efficient management, and timely updates of plant documents, including all departmental Standard Operating Procedures (SOPs), the Quality Manual, Site Master File (SMF), Validation Master Plan (VMP), Training Manual, Safety Manual, logbooks, registers, validation protocols and reports, and qualification protocols and reports. These critical documents are consistently managed in alignment with stringent Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) guidelines and industry standards to maintain regulatory compliance and operational excellence.
9. Engage in the meticulous review, diligent approval, efficient management, continuous monitoring, and timely updates of a range of product-related documentation, including Master Formula Records (MFR), Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), specifications, Standard Testing Procedures (STP), Analytical Work Sheet Records (AWR), Certificates of Analysis (COA), and various validation protocols such as Process Validation, Hold Time Studies, Stability Studies, Analytical Method Validation, and Cleaning Validation, as well as their corresponding detailed reports. Additionally, oversee and manage deviations, conduct thorough investigations, and implement necessary change controls regarding manufacturing processes, all in strict accordance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) guidelines to ensure consistent regulatory compliance and adherence to quality standards.
10. Accountable for overseeing market complaint investigations, managing product recalls, and ensuring compliance with relevant regulations. Tasked with creating investigation procedures for incidents such as Out of Specification (OOS), Out of Trend (OOT), Out of Compliance (OOC), and Deviations. Responsible for reviewing, approving, implementing, and validating Corrective Action and Preventive Action (CAPA) plans, and facilitating coordination between departments for the exchange of Quality Management System (QMS) related documentation.
11. Collaborate with Quality Control and Production to maintain product quality and regulatory compliance, playing a key role in document management decisions to ensure that international standards are met for processing or distribution, fostering a comprehensive approach to quality assurance and regulatory adherence.
12. Undertake the responsibility of organizing and conducting interviews, as well as overseeing the recruitment procedures for selecting and onboarding Quality Assurance personnel within the organization.
13. Assume supplementary tasks and duties assigned by management as needed, showcasing adaptability and a readiness to contribute beyond regular responsibilities when called upon.
Preferred candidate profile
Skills:
- Advanced Analytical Thinking
- Exceptional Problem-Solving Abilities
- High Attention to Detail
- Strong Leadership and Team Management Skills
- Expert Knowledge of WHO-GMP, FDA, and International Regulatory Standards
- Effective Communication and Documentation Skills
- Proficiency in Data Analysis and Quality Control Tools
- Strategic Planning and Risk Management
- Audit Preparation and Management
Experience:
- 10+ years in Quality Assurance within the pharmaceutical industry
- Extensive experience with WHO-GMP, FDA, EMA, and other regulatory audits
- Proven track record in leading large QA teams and multi-site operations
- Hands-on experience with quality systems implementation and maintenance
- Experience in developing and delivering training programs
- Successful management of corrective and preventive action plans
- Collaboration with regulatory bodies and industry groups
Qualifications:
- Masters degree in Pharmaceutical Sciences, Chemistry, or a related field
- Advanced Certifications in Quality Management (e.g., Six Sigma Black Belt, ISO Lead Auditor)
- Professional memberships in recognized QA organizations (e.g., ASQ, PDA)
- Continuous professional development in latest QA and regulatory trends
- Publications or presentations in relevant industry conferences or journals
- Specialized training in regulatory compliance and audit management
- Vacancy details:
- Department:Production Manager
- Qualification: B.Sc , B.Pharma MS/M.Sc(Science) , M.Pharma
- Experience:5 – 10 years
Job description
Roles and Responsibilities:
1. Responsible for manufacturing and development of Tablets, Capsules & Liquid Oral products.
2. To ensure GMP & GDP Compliance in the Production department.
3. Prepare Machine URS / DQ and execute the qualification of IQ/OQ/PQ.
4. Preparation of SOP’s and master formulation record for production department.
5. Independent handling of manufacturing of Tablet, Capsule & Liquid Oral.
6. Co-ordination with other depts like production, Stores, QC, QA, EHS, Eng etc. regarding smooth operation of the production & preparing Monthly/weekly/daily Production plans.
7. Accountable for completing of batch as per the production plan, Control on daily production output.
8. Review and Compliance of executed Batch Record and submit to QA in within time.
9. To allocate the work among operators on a day-to-day basis guiding the operators and troubleshooting for smooth operation of machines/processes.
10. Optimizing man & machine utilization to achieve pre-set production targets.
11. To co-ordinate with Engineering dept for scheduling of preventive maintenance and timely availability of utilities/breakdown/repairs of machineries and equipment.
12. To coordinate with QA and Technical services dept for timely release of batches, IPQC tests, line clearances and for validation of processes, equipments as required.
13. Responsible for Handling cleaning procedure for Machine, area, wall as per SOP in each stage of Production.
14. To ensure that environmental conditions, as specified are achieved and maintained in the respective areas.
15. Maintaining Batch record, calibration records, equipment utilization log and self-hygiene records etc.
16. Verification of raw material at the time of receipt as per BMR.
17. Record yield and reconciliation at various stages of manufacturing.
18. To carry out various manufacturing activities like Granulation, compression, Coating, Capsule filling and Polishing, Liquid Oral Manufacturing as per Batch Manufacturing record.
19. To carry out various Packing activities like Blister, Alu-Alu, Strip Packing, Bottle filling sealing Packing and Secondary Packing as per BPR.
20. Handling all Production Machinery like FBD, RMG, OB, CO Mill, Shifter, Roll Compactor, Compression Machine, Auto Coater, AF 90 Capsule filling Machine, Liquid Manufacturing Plant and All Packing Machine.
21. co-ordinates with vendors and Purchase officer for purchasing items like FBD bags, Food Grade oil/Grease, Sieves/Screens, Punches & Dies and spares/machines Change parts.
22. Accountable for handling changeover Procedure and make sure it meet Product specifications as per batch to be manufactured.
23. Responsible for handling process validation of new product and documentation of same.
24. Responsible for investigation of non-conformities, identification of root cause, suggestion of CAPA, preparation review and compliance of investigation reports.
25. Responsible for raising and execution of change control and CAPA and its implementation through eQMS software.
26. Responsible for preparation and review of Risk assessment related to process and product attributes.
27. Responsible to ensure the work discipline on shop floor in department & G.M.P. Compliance.
28. Responsible for audit preparation and audit compliances for Production department.
29. Responsible for Performing & complying with Internal & External Audits.
30. Performing other responsibility as instructed by Management whenever required.
31. Actively participating, Conducting and Leading Internal or External Audit and Self Inspection by regulatory agencies and internal/external auditors.
Preferred candidate profile
Core Skills & Competencies:
1. In-depth knowledge of WHO GMP regulations and standards
2. Should have Handle WHO GMP, cGMP, ISO and other countries audit.
3. Strong leadership and team management skills
4. Excellent organizational and planning abilities
5. Proficiency in production management software (Pharmacloud) and MS Word, MS Excel.
6. Strong problem-solving and decision-making skills
7. Good communication and interpersonal skills
8. Knowledge of regulatory requirements in pharmaceutical manufacturing
Experience and Qualifications
- Bachelor’s & Master degree in pharmacy, or a related field (masters preferred)
- Minimum of 5 years of experience in production management within the pharmaceutical industry
- Proven experience in improving production processes and efficiency
- Familiarity with GMP and other regulatory standards
