Quality Manager - CL

Parexel • Full-time • Hyderabad, IN • 5d ago

Key Accountabilities

General Quality Manager

Identify process improvement opportunities and champion their implementation, as assigned.
Work independently and provide expert advice to groups within the organization.
Provide mentoring, leadership, direction and training to new and existing Quality Specialists.
Participate in SOP and process development as assigned.
Participate in development of quality-related processes and tools.
Provide quality consultancy to Functional Leads, Line Manager, and / or Project Leader / Project leadership.
Work with the relevant training functions including Parexel Learning & Development and Operations. Assist with the development or enhancement of training materials, as assigned.
Complete or oversee the completion of assigned quality interventions / targeted / independent quality assessments. Verify compliance with GxP guidelines, local regulations, protocol, Parexel procedures and / or sponsor requirements.
Develop designated operational group(s) specific interventions / targeted / independent quality assessments as assigned.
Provide audit and inspection support as assigned. This may include: providing assistance / advice for audit/inspection preparation; representing Quality Management in audits and inspections as required; reviewing assigned audit / inspection responses. Request audits of investigational sites, local offices or processes as needed.
Provide support for management of quality issues. Facilitate and advice on corrections and corrective actions related to designated quality issues. Develop preventive actions and ensure resolution by Operational or Line Management staff, or Quality Management. Facilitate local compliance to the corrective and preventive action (CAPA) program.
Perform Process Lead role for enterprise accounts and / or growth accounts or provide process support, as assigned.
Attend (or where required, lead) internal quality-focused meetings.
Maintain a familiarity with Parexel systems and related processes, Parexel Standard Operating Procedures and relevant regulations and guidelines.
Perform other process, quality or training related tasks for particular workgroups (e.g. Line Managers, Leads) or project teams as assigned.
Remain informed about developments in relevant regulations and guidelines.
Share information in an open, balanced and objective manner with other
Quality Management and other Parexel professionals to maintain positive, results-oriented team environment.
Deputize for manager as assigned.
International travel required of approx. 10%

Head of Quality Control

May execute QC checks of Medicinal Products and other quality critical Clinical Trial Supplies during receipt, production and distribution
Oversee all Quality Control activities in local depot/warehouse
Instruct and train QC staff and other depot staff as needed
Perform QC release of Medicinal Product batches and batches of other quality critical Clinical Trial Supplies (CTS)
Oversee premise and equipment (P&E) maintenance and cleaning
Approve Product Specifications and Master Batch Records
Review and approve Production Batch Records and Test Records
Perform and support P&E qualification/validation activities as appropriate
Undertake local P&E Quality tasks as defined in Parexel procedures to cover local QA tasks
Oversee local Premise-specific and operational related change control procedures and quality issue (QI) reporting
Receive advice from with local QPs (Qualified Person), RPs (Responsible Pharmacist) or APs (Authorized Persons)
May act as Backup for the Responsible Pharmacist in LATAM-region as per local legislation (not allowed in other regions). Details on Delegation rules and requirements are documented in UP-CTSL-WW-005 Personnel Responsibilities.

Skills

Excellent interpersonal, verbal and written communication skills.
Client-focused approach to work.
Project management and leadership abilities.
Ability to work independently, takes initiative, and has a flexible approach with respect to work assignments and new learning.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills.
Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization.
IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions.
Ability to travel as needed for the position.
Ability to think and work globally and be culturally aware.
Ability to handle several highly complex projects/tasks simultaneously, potentially spanning different SBUs.

Knowledge And Experience

English proficiency (written and oral English)
Knowledge of GMPGDP regulations required
Training experience, as appropriate, required
Relevant experience in Quality Management preferred
Relevant experience in the Clinical Research field (GCP), clinical or medical experience or other relevant experience in the areas Logistics Quality Management (LQM) support preferred
Technical Leadership / Project Management / Technology / Business Operations experience, as appropriate, preferred

Additional Requirements For Head Of Quality Control Role

Receive approval from local QPs (Qualified Person), RPs (Responsible Pharmacist) or APs (Authorized Persons) before entering into the HQC-role
Receive approval from local GMP/GDP surveillance authorities before entering into the HQC-role
Local language proficiency (written and oral)

Experience

5-8 years of relevant experience.

Education

Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Master’s degree in a science, technology or industry related discipline, preferred

Related Jobs

Hospital Pharmacist | Hyderabad, Telangana, India

IKIGAI HOSPITALS • Full-time • Hyderabad, Telangana, India • 1m ago

Pharmacist Clinical Pharmacist

1m ago

Lab Technician - Hyderabad, Telangana, India

DoctorC • Full-time • Hyderabad, Telangana, India • ₹ 25k - ₹ 35k / month • 1d ago

Medical Lab Technician Clinical laboratory Technician

1d ago

Patient Safety Physician

Parexel • Remote • Remote (Serilingampalli, Hyderabad, India) • 5d ago

Doctor

5d ago

Doctor – Palliative Care

Pallium India • Full-time • Hyderabad, Telangana, India • 1w ago

Doctor

1w ago

Lab Technician

oscon • Full-time • Hyderābād, Telangana, India • ₹ 90k - ₹ 95k / month • 1w ago

Medical Lab Technician Clinical laboratory Technician

1w ago

Microbiology Technician

Fernandez Hospital • Full-time • Hyderābād, Telangana, India • ₹ 20k / month • 1w ago

Medical Lab Technician

1w ago

Mbbs Doctor | Hyderabad, Telangana, India

3SG MEDICAL PLACEMENTS • Full-time • Hyderabad, Telangana, India • 1w ago

Doctor Medical Doctor

1w ago

Business Development Executive | Hyderabad, Telangana, India

Placemein HR Solutions • Full-time • Hyderabad, Telangana, India • 1w ago

Doctor Medical Doctor

1w ago

Dental Ceramic Layering Technician | Hyderabad, Telangana, India

Area Dental Hospital • Full-time • Hyderabad, Telangana, India • ₹ 15k - ₹ 25k / month • 1w ago

Dentist Dental Practice Associate

1w ago

Molecular Lab Technician | Hyderabad, Telangana, India

Limagrain • Full-time • Hyderabad, Telangana, India • 1w ago

Medical Lab Technician Clinical laboratory Technician

1w ago