Awais Ali
Luton,Bedfordshire
Summary
Assertive Production Manager with expertise in healthcare administration and service management within the Health and Pharmaceutical industry. Ensures compliance with MHRA, GMP regulations and enhances service delivery while managing multidisciplinary teams and optimising resource allocation. Drives continuous improvement initiatives to deliver high-quality, patient-centred care. Resourceful professional with strong leadership and team management abilities. Cultivates effective cross-functional communication to support operational goals and enhance productivity. Demonstrates adaptability in problem-solving and decision-making, while maintaining a focus on compliance. Experienced in managing production workflows with focus on optimising processes and enhancing team performance. Proven track record in driving operational improvements and ensuring timely delivery of high-quality products. Strong communication skills and collaborative approach to problem-solving. Goal-oriented manufacturing professional successful at leading productive teams and increasing profitability with streamlined processes and continuous improvement strategies. Resourceful and adaptable collaborator with knowledge of enhancing operations and maintaining high standards of safety practices. Proven leader with dedication to organisation and good management practices.
Overview
5
5
years of professional experience
Work History
Aseptic Production Manager
Quantum Pharmaceuticals Limited
03.2026 - Current
- Managed aseptic production operations within a GMP/GDP regulated pharmaceutical environment, ensuring compliance with SOPs, quality standards, and regulatory requirements.
- Supervised daily manufacturing activities to ensure products were produced, stored, and documented accurately in line with approved procedures.
- Reviewed and approved production records, batch documentation, and operational instructions to maintain audit readiness, and product quality.
- Oversaw equipment maintenance, process validation, environmental monitoring, and departmental compliance within sterile manufacturing areas.
- Worked closely with Quality Assurance and Quality Control teams to support GMP compliance, investigations, process improvements, and product release activities.
- Ensured staff training and competency assessments were completed and maintained according to operational and regulatory requirements.
- Managed staffing levels, shift planning, recruitment, and departmental workloads to meet production targets and business needs.
- Led, trained, and supported production teams through performance management, coaching, development plans, and regular feedback sessions.
- Monitored KPIs, departmental performance, and operational efficiency while implementing continuous improvement initiatives.
- Supported supplier and contractor compliance processes, including material approvals, storage controls, and documentation management.
- Investigated deviations, incidents, and operational issues, implementing corrective and preventive actions where required.
- Maintained compliance with Health & Safety legislation by conducting risk assessments, promoting safe working practices, and ensuring staff adherence to safety procedures.
- Coordinated cross-functional communication to support business operations, quality objectives, and customer requirements.
- Demonstrated strong leadership, problem-solving, and decision-making skills within fast-paced, aseptic, and pharmaceutical manufacturing environments.
ASEPTIC PRODUCTION SUPERVISOR
Quantum Pharmaceuticals Limited
05.2024 - 02.2026
- Experienced Aseptic Production Supervisor with expertise in sterile manufacturing, aseptic compounding, and pharmaceutical production within MHRA-licensed facilities.
- Strong knowledge of GMP, GDP, GxP Quality Management Systems, EudraLex Vol 4, COSHH, and Health and Safety regulations.
- Skilled in supervising and managing aseptic production teams, ensuring compliance with SOPs, company policies, and audit requirements.
- Experienced in compounding cytotoxic drugs, CIVAS, and TPN products in controlled sterile environments while maintaining high-quality standards.
- Proficient in overseeing daily production operations, including environmental monitoring, cleaning processes, raw material assembly, and process validation activities.
- Demonstrated ability to manage workload allocation, staff rotas, production targets, and customer demands, to maximise productivity and operational efficiency.
- Experienced in quality assurance activities, deviation investigations, risk management, incident handling, and implementation of corrective and preventive actions (CAPA).
- Skilled in maintaining accurate documentation, batch records, and audit trails in line with regulatory and compliance standards.
- Proven ability to train, mentor, and develop production staff through training programmes, performance reviews, PDPs, return-to-work interviews, and coaching sessions.
- Experienced in people management, including performance management, disciplinary procedures, conflict resolution, absence management, and employee engagement.
- Strong leadership skills with the ability to build collaborative, high-performing teams, while promoting continuous improvement and operational excellence.
- Competent in identifying process improvement opportunities, implementing change requests, and supporting continuous improvement initiatives across operations.
- Experienced in handling customer complaints, resolving complex operational issues, and maintaining high standards of customer service.
- Proficient in Microsoft Office and highly computer literate, with strong organisational, communication, and problem-solving abilities.
- Able to work autonomously, make critical operational decisions, and adapt effectively within fast-paced pharmaceutical manufacturing environments.
PRODUCTION SUPERVISOR (Department Head)
Bristol Laboratories Limited
12.2022 - 05.2024
- Ordering raw materials and tech equipment from vendors.
- Managing intra and inter-company transfers of both equipment and finished products under regulatory body guidelines.
- Run GAP analysis to create an action plan to achieve the organizational targets and fill in performance gaps.
- Building liaison with regulatory bodies to manage CMC affairs.
- Managing process validation, cleaning validation and validation of change in API source by new vendor.
- Reviewing & revising BMR’s and making batch and stability protocols as per validation data.
- Raising CCP and change initiation and closure.
- Manage & organize production personnel to meet agreed production schedules and targets.
- Operating SAP system and requesting, issuance and printing of allocation sheet for MBR’s.
- Initiating or recording change control and doing CAPA using QAMS.
- Allocation of daily jobs to production team and monitoring the activity.
- Train the operators to perform the dispensing activity and documentation as per SOP.
- Maintaining In process quality assurance (IPQA).
- Following the Good documentation (GDP) and current good manufacturing practice(cGMP).
- Maintaining Data integrity and ALCOA module in manufacturing.
- Follow and adhere to the health and safety instructions, Ethical Practices and ensure subordinates are following PPE, health safety procedure and company policy and patient safety and quality of the product is paramount in all activity.
- Request for BMR. Ordering of material from warehouse.
- Follow up QC for release of material and COA, if required.
- Carry out verification of scales/balances and all other equipment at the required intervals as per the SOP.
- Ensure line clearance as per SOP's and sign documents.
- Check and ensure raw materials prior to weighing in dispensary as per SOP.
- Check and sign in and Sign Out raw material as per SOP on SAP.
- Preparation and regular review of SOP relating to the area.
- Ensure effective utilization of the available resources and monitor their results to assess the workability of the procedures.
- Complete documentation in real time by following Good Documentation Practices for the allocated operations/tasks including logbooks.
- Follow S.O.P. and B.M.R instructions for all operation / cleaning activities in the area.
- Report deviations, incidents and accidents. Investigate to find out the root cause and take CAPA.
- Help to investigate the market complaints and Out of Specification complaints if required.
HEALTHCARE SPECIALIST
Lloyds Pharmacy
London
01.2022 - 12.2022
- Issuing stock items and prepared prescription.
- Dispensing Prescription and counter checking prescription errors.
- Regulatory Management.
- Quality control of medications.
- First in first out compliance.
- SOP compliance.
- Needle exchange claims.
- E-prescription handling.
- OTC services.
- Patient Counselling.
- GHP & GMP compliance.
SENIOR CLINICAL RESEARCH ASSOCIATE
DRK Pharma Solutions Gmbh Pvt Limited
12.2020 - 09.2021
- Monitoring of different ongoing Clinical Trials as a Compliance Officer.
- Liaising with Doctors, Consultants and Investigators conducting Trials.
- Managing Regulatory authority applications and approvals.
- Conducting site selection visits (SSV), site initiation visits(SIV).
- Independent site monitoring.
- Verifying data on CRFs, monitoring schedules/visits of patients according to protocol, filing and collating trial documentation and reports, archiving study documentation and correspondence, preparing Final Reports, and detailed follow-up letters after monitoring visits.
- Training of the Clinical Trial site staff regarding protocol, Investigational Product Management, Case Report Form filling and Good Documentation Practice.
- Preparation of Regulatory dossiers; National Bioethics committee and Drug safety and monitoring boards.
- Timely reporting of SAEs, in the study, to sponsor and IRB/Ethics Committee.
- Close and timely Correspondence & coordination with the international study team, including data manager, study manager, pharmacovigilance departments.
- E-TMF preparation of Trials.
- Daily updating the e-CRF, Electronic Case Report Forms.
Education
MSc - Pharmaceutical Science with Industrial Practice
UNIVERSITY OF GREENWICH
UK01-2023
PHARM.D. - Pharmaceuticals
UNIVERSITY OF THE PUNJAB
01-2020
Skills
- Leadership and team management
- Healthcare Administration
- Communication skills
- Technical and analytical skills
- Managing project initiation and closing
- Driving team towards success
- Budget and Resource Management
- Compliance and Governance
- Project Management
- Problem-solving and decision-making
- IT and Systems Skills
- Production management
- Process validation
- Regulatory compliance
- Team building
- Cross-functional communication
- Continuous improvement
- Operational efficiency
- Production scheduling
- Equipment maintenance
- Quality assurance
Research Work
- A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, a Recombinant Novel Coronavirus Vaccine (CHO cell) for Prevention of COVID-19.
- A randomized double-blinded control clinical trial of DWJ1248 in prevention of covid-19 infection after exposure of SAR-COV-2.
- VIDSAM (vitamin D) a combined clinical Trial Project by Queen Mary University of London and University of Punjab to check the malnutrition among children.
Portfolios and Profiles
http://linkedin.com/in/awais-ali-187838126
Projects
- A review of approaches to rapid drug repurposing in the search for Antiviral therapies, MSc research project
- Evaluating the Attitude, Knowledge and Perception of Pharmacist Regarding Generic Prescribing, Clinical pharmacy project
- Formulation design and Optimization of Sustained Release pellets of Salbutamol, Pharmaceutical technology project
Languages
English
Proficient
C2
Urdu
Proficient
C2
Hindi
Proficient
C2
Punjabi
Proficient
C2
Arabic
Elementary
A2
Timeline
Aseptic Production Manager
Quantum Pharmaceuticals Limited
03.2026 - Current
ASEPTIC PRODUCTION SUPERVISOR
Quantum Pharmaceuticals Limited
05.2024 - 02.2026
PRODUCTION SUPERVISOR (Department Head)
Bristol Laboratories Limited
12.2022 - 05.2024
HEALTHCARE SPECIALIST
Lloyds Pharmacy
01.2022 - 12.2022
SENIOR CLINICAL RESEARCH ASSOCIATE
DRK Pharma Solutions Gmbh Pvt Limited
12.2020 - 09.2021
MSc - Pharmaceutical Science with Industrial Practice
UNIVERSITY OF GREENWICH
PHARM.D. - Pharmaceuticals
UNIVERSITY OF THE PUNJAB