Renu Varma
Birmingham,West Midlands
Summary
Experienced Manager with over 11 years in Pharmaceutical industry. Excellent reputation for resolving problems and improving customer satisfaction. Offers flexible schedule to deliver on team goals.
Overview
13
13
years of professional experience
5
5
years of post-secondary education
Work history
General Manager
Medicines Manufacturing Facility
12.2022 - 04.2025
- Management of 3 Manufacturing sites with the purpose of manufacturing medicines for patient use for autoimmune conditions
- Management of large teams 30-40+ including contractors having access to the facilities for maintenance
- Working closely with the Assistant Director of Operations
- Supervise and support Quality and Production and Service delivery managers to facilitate and ensure Good Manufacturing Practice services
- Ensuring robust processes are set up and maintained.
- Manage resource management throughout the business to ensure a timely delivery of services
- Provide expert input across the Medical School in relation to the operation of the manufacturing business.
- Execution and effectiveness of any strategic decisions relating to the business
- Manage the Senior Management Team in the provision of training to personnel in line with legislation, national and local standards, and expectations.
- In liaison with the management team and Clinical Research Compliance Team, ensure overall efficiency performance and quality of the business functions and services provided, and ensure dissemination of information to relevant parties are applicable.
- Ensure any issues noted are dealt with appropriately. Support the Senior management Team in the promotion of the business to diverse network of academic, clinical and commercial customers, maintaining relationships and resolving high level client issues.
- Manage the Production and Quality Managers in the maintenance of the existing Medical Health Regulation Agency and Human Tissue Authority licences on behalf of, and in close partnership with, the Designated Individual and Qualified Person.
- Ensuring licences are fit for inspection by the Medical Health Regulation Agency/ Human Tissue Authority and compliant with the regulations and codes of practice.
- Persons Designated on the Human Tissue Authority licence
- Manage Quality Managers in preparation for, management of, and responses to any external audits and inspections, liaising with all relevant stakeholders as appropriate.
- Active member of the Human Tissue Oversight Committee
- Ensure emerging legislation, research, governance, ethical conduct, and good practice is appropriately embedded in the business through the Pharmaceutical Quality System
- Facilitate the further development of the Quality System and contribute to its execution, ensuring fit for purpose
- Input and review of quality check and audits within the company, contribute to resolution of any issues raised, leading to operation response.
- Review and complete the appropriate contracts such as, Material Transfer Agreements, Service Level Agreements and Quality Technical Agreements
- Identify areas of non-compliance
- Oversee appropriate resolution by Corrective Action Preventative Actions. Develop and maintain systems to underpin financial oversight.
- Budget planning costing for clients and cost recovery for the provision of services
- Ensuring the facility and associated staffing structures remain effectively self-funded through their activities
- Led cross-functional teams to enhance operational efficiency and streamline production processes.
- Developed and implemented strategic initiatives to improve product quality and compliance with industry regulations.
- Coordinated training programmes for staff to ensure adherence to safety protocols and best manufacturing practices.
- Oversaw budget management and resource allocation to facilitate successful project execution and operational stability.
- Fostered a culture of continuous improvement by encouraging employee feedback and implementing innovative solutions.
- Managed relationships with suppliers and stakeholders to secure necessary materials and maintain supply chain integrity.
- Analysed production metrics to identify trends and drive informed decision-making for future operational strategies.
- Successfully negotiated contracts with suppliers to reduce costs.
- Regularly reviewed performance data, driving continuous improvement efforts.
- Managed key stakeholder relationships for smoother project completion.
- Oversaw all aspects of daily operations, ensuring smooth running of the organisation.
- Established a positive work environment which promoted staff morale and productivity.
- Streamlined communication processes for improved team collaboration.
- Maintained compliance with industry regulations at all times.
- Allocated resources to teams and projects based on need, performance and availability.
- Worked with board of directors to establish objectives and decisively lead operations.
- Established budgets based on historical, current and forecasted business data.
Quality Manager
Medicines Manufacturing Facility
12.2018 - 12.2022
- Lead the validation and quality control of in-process investigations and release assays. Approving specifications, sampling instructions and test methods to monitor factors which may affect product quality, assess intermediate, bulk and finished product.
- Proactive in ways to further to improve quality and compliance. Continually monitor and trend quality control parameters and implement improvements when required.
- Report frequently reoccurring issues related to quality deviations, and quality standards and recommend ways of dealing with them.
- Development and implementation of written policies, standard operating procedures, and quality-controlled documents, their ongoing review and revision.
- Participate in internal audits, to include planning, performing, reporting of findings, making recommendations, and implementing improvements
- Amendment of SOPs that are no longer fit for purpose by recommending, developing and implementing new, appropriately validated procedures.
- Approval and monitoring of suppliers
- Approval and rejection of materials and packaging materials
- Designation and monitoring of storage conditions for materials and products.
- Ensure facility, systems and equipment are validated
- Ensure production/ batch records are signed by an Qualified person
- Facilitating the development of new therapies by assisting with the translation of research protocols into clinical protocols, with a view for regulatory validation, and compliant to cGMP standards.
- Pre-Final check of Final Product in readiness for QP release.
- Approving and monitoring contracts with third parties and ensuring they are in line with the requirements of the MHRA, the HTA and any other relevant bodies with regards to quality.
- Preparation of new, or renewal of existing, regulatory licence applications in regards to quality control
- Preparation and close involvement during regulatory inspections e.g. MHRA, HTA, Health and Safety.
- Developed and implemented quality management systems to ensure compliance with industry regulations.
- Conducted regular audits and inspections to assess adherence to quality standards and identify areas for improvement.
- Trained and mentored staff on quality assurance practices, fostering a culture of continuous improvement.
- Collaborated with regulatory agencies during inspections to demonstrate compliance with quality assurance requirements.
- Reviewed and approved documentation related to quality control processes, ensuring accuracy and completeness.
- Ensured consistency in product quality with regular inspections and tests.
- Managed audits of manufacturing operations, ensuring compliance with industry regulations.
- Handled non-conformance issues proactively, reducing production delays significantly.
- Led company-wide quality campaigns, fostering a culture of excellence and continuous improvement.
- Ensured adherence to health and safety guidelines within the organisation protecting employee wellbeing.
- Evaluated manufacturing processes regularly and documented analysis results for business improvement and growth.
GMP Production
Medicines Manufacturing Facility, Microbiome Treatment Centre
05.2018 - 12.2018
- Material Receipt
- Cleaning and Disinfection of a Non Sterile Grade D laboratory
- Environmental Monitoring FMT Manufacture
Lead Analyst
Boots Contract Manufacturing
Nottingham
10.2017 - 02.2018
- Company Overview: Nottingham
- HPLC, GC Stability Testing and Maintenance
- Working Review
- Scrutiny of Chromatograms
- Trained Trainer
- SOP Reviewer and Amendments
- Reference Standards testing
- Nottingham
Quality Control Analyst
Boots Contract Manufacturing
Nottingham
10.2016 - 09.2017
- Company Overview: Nottingham
- Support Delivery of an efficient and compliant testing service to internal and external customers
- Manage work priorities inline with deadlines
- Performing a variety of routine chemical and physical tests of medicinal and healthcare products to Good Laboratory Working Practice
- Maintaining consistency and focus everyday particularity on quality and compliance
- Review test results ensuring any Out Of Specification are promptly escalated
- Communicate and problems and delays to projects and escalate through appropriate routes
- Support a positive culture of safety to ensure the laboratory meets all health and safety requirements
- Routine Testing included, Karl Fisher, Titrations, GC, HPLC and Chromeleon, Dry Matter, Loss of Drying, UV Vis Spectroscopy, Limit Tests, FTIR, NIR, Viscosity, Density, TIN, ZINC
- Preparation of Solutions
- Calibration of Equipment
- Monitoring of Equipment
- Verified P&G scent test
- Nottingham
Microbiologist
Mondelez International
Birmingham
09.2016 - 10.2016
- Company Overview: Birmingham
- Sample and Media Preparation
- Testing for Salmonella, TVC, Yeast and Mould
- Pathatrix and PCR
- Documentation
- Birmingham
Forensic Technician/ Toxicology
ESG Ltd: Toxicology Department
Burton on Trent
08.2014 - 09.2016
- Company Overview: Burton on Trent
- Sample receipt as per Chain of Custody Process
- Immunoassay analysis Beckman Coulter
- Troubleshooting of equipment
- Confirmation of Drugs of Abuse using SPE, GCMS, and Head Space GCMS
- Data Processing
- Hair Analysis via UHPLC Shimadzu
- Report Generation
- Non Compliance
- Customer Queries
- Prioritising workload and working to strict deadlines as per court orders
- Good documentation practice
- Operation of Excel Spreadsheets for results, data entry into internal lims systems
- Client Communication
- Monitoring and Training new staff
- Quality Assurance
- Writing SOPs and amending if required on review.
- Sharp attention to detail to ensure no mistakes are made delivery of high quality of work
- Booking in appointments for Drugs & Alcohol testing
- Uploading certification for Drugs & Alcohol testing
- Issuing approved certification
- Routine Proficiency Testing
- Documenting all purchases made in the department via Purchase requisitions and excel
- Stock take
- Ordering
- Client Confidentiality
- Waste Management
- Burton on Trent
Microbiology Department
Exova UK Ltd
Birmingham
12.2013 - 03.2014
- Company Overview: Birmingham
- Sample Sorting Job Numbers and LSN Numbers
- Aseptic Filtration
- Plating and Pouring
- Labelling
- Legionella, S&B, TVC (1,2 and 3 Day)
- ECOLI and Coliforms, Pseudomonas, SRB, NRB, Yeast and Mould
- Weighing
- Preparation of media
- Restock of materials
- Cleaning and Disinfection
- Birmingham
Analytical Chemistry Internship
Avans Hogeschool Breda
10.2012 - 03.2013
- Company Overview: Netherlands
- Trained in GC and HPLC
- Fire Investigation Research
- Thin Layer Chromatorgraphy
- Fourier Transform Infrared
- Polilight PL500
- UV Vis Spectroscopy
- Assistant Teaching
- Laboratory preparation student classes
- Netherlands
Education
International post graduate course - PCR principles and Parameters
Avans Hogeschool
10.2012 - 03.2013
BSc Forensic Science (Honours) - undefined
University of Wolverhampton
01.2009 - 01.2012
BTEC National Diploma - Forensic
Birmingham Metropolitan College
01.2007 - 01.2009
Skills
- Project Management
- Client Engagement
- Decision Making
- Strategic Thinking
- Leadership
- Auditing
- Financial budgeting
- Business development
- Regulatory compliance
- Supply chain management
- Client relations
- Decision-Making authority
- Process Improvement
- Operations management
Training
- MACSQuant Instrument Training, MACS Academy, Miltenyi Biotech Ltd, Surrey UK, 2023-03-15
- GMP and ATMP Training, Pharmaceutical Training International, 2018-09-25
- Problem Solving Training Course, Inspired Pharma, 2022-11-04
- GMP Training Course, Inspired Pharma, 2023-02-24
- GMP Training Course, Inspired Pharma, 2022-02-10
- GMP Training Course, Pharmaanswers Ltd, 2020-11-26
- Good Clinical Practice, NIHR CPD Certification, 2019-10-01
- Good Clinical Practice, NIHR CPD Certification, 2021-12-06
- Quantum Cell Expansion System Operator Training, Terumo Blood and Cell Technologies, 2021-01-07
- Good Documentation Practice, Training Courses, 2021-05-26
- Materials Management, Training Courses, 2021-05-25
- CRCT Audit Training, Training Courses, 2021-05-11
- Cell Counts Nucleocounter NC200, Training Courses, 2021-05-07
- Q-Pulse Document Module Trainer, Training Courses, 2021-02-23
- Receipt and Storage of IMP, Training Courses, 2021-07-27
- Clinical Research in a Laboratory, Training Courses, 2019-07-17
- Non Conformance, Training Courses, 2019-01-29
- Use of Q-Pulse and QMS management: Intermediate QMS Document development and Control, Training Courses, 2019-01-09
- Training Procedures, Training Courses, 2019-01-09
- Training Procedures, Training Courses, 2019-01-21
- Use of Q-Pulse and QMS management: Advanced document development and control, Training Courses, 2019-01-15
- Change Control, Training Courses, 2019-01-13
- FMT Request forms, Training Courses, 2018-07-27
- Diversity in the workplace, Training Courses, 2018-05-10
- Temperature Monitoring Tutela Check IT, Training Courses, 2018-06-18
- Sapphire Sample Data Entry, Training Courses, 2018-08-07
- Collection, Transfer and recording of material and research samples, Training Courses, 2018-08-06
- Environmental Monitoring, Training Courses, 2018-08-02
- Data Protection, Training Courses, 2018-05-22
- Dose Preparation Training, Longboat Navigating Clinical Trials, 2021-02-12
- ICH GCP E6 (R2), Longboat Navigating Clinical Trials, 2021-05-20
Timeline
General Manager
Medicines Manufacturing Facility
12.2022 - 04.2025
Quality Manager
Medicines Manufacturing Facility
12.2018 - 12.2022
GMP Production
Medicines Manufacturing Facility, Microbiome Treatment Centre
05.2018 - 12.2018
Lead Analyst
Boots Contract Manufacturing
10.2017 - 02.2018
Quality Control Analyst
Boots Contract Manufacturing
10.2016 - 09.2017
Microbiologist
Mondelez International
09.2016 - 10.2016
Forensic Technician/ Toxicology
ESG Ltd: Toxicology Department
08.2014 - 09.2016
Microbiology Department
Exova UK Ltd
12.2013 - 03.2014
Analytical Chemistry Internship
Avans Hogeschool Breda
10.2012 - 03.2013
International post graduate course - PCR principles and Parameters
Avans Hogeschool
10.2012 - 03.2013
BSc Forensic Science (Honours) - undefined
University of Wolverhampton
01.2009 - 01.2012
BTEC National Diploma - Forensic
Birmingham Metropolitan College
01.2007 - 01.2009