Quality Investigation lead

ROLE SUMMARY
S ummarize the primary purpose & key accountabilities of the role. Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.
Responsible for championing the overall site investigations system (manufacturing and laboratory investigations) and ensuring the effective operation of the site investigations in adherence to the site and global SOP requirement.
ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 key result areas that highlight accountability and level of judgment required .
Key Areas
Activities
Reporting/Responsibilities

• Establish effective platform to implement a robust investigation process (OBW for Investigation)

• Liaise and influence the cross functional team to drive the site investigations to meet the supply reliability

• Demonstrate the agility and lead the site investigation team to achieve the key quality and supply metrics

• Championing in effective implementation of global investigations requirements at site

• Monitor, review, develop and implement the action plan for investigation program & metrics sustenance

• Providing the inputs to network sites and participating in global investigation system enhancement

• Derive appropriate training methodologies to improve and maintain the capability and competency of investigators and approvers

• Develop succession planning for S ite investigations Team .

• Undertake and implement improvement plans to meet the Quality department's goals .

• Evaluate data and trends, report results to management.

• Assist with and/ or undertake investigations and apply relevant and necessary actions/ systems to ensure appropriate levels of compliance.

Compliance

• Interface with cross functional teams to provide feedback on operations and compliance status .

• Responsible for reviewing, developing, and introducing systems, practices and cultural changes that enable the Process Stream to meet business demands within agreed time frames and expected GXP standards.

• Promote strategies to ensure all deviations and corrective and preventive actions (C APAs ) are recorded, investigated and closed within established timeframes .

• Notify appropriate management of missed deadlines .

Team Management

• Manage and direct the functions and staff of investigations team to ensure efficient and effective systems are in place to provide sound service to internal and external stake holders .

Continuous Improvement

• Lead the team to implement continuous improvement actions through multiple Lean Six sigma projects for system and process enhancement

• Liaise with Pfizer center to represent Vizag site for Global procedural improvements.

• Mentor the team in critical thinking process

Cultural Attributes

• All Pfizer colleagues are expected to conduct themselves in line with the Pfizer Values -

Courage, Equity, Excellence & Joy
Statutory Obligations

• All colleagues are expected to conduct themselves in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment, and bullying.

Environmental Health and Safety

• Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System .

ESSENTIAL REQUIREMENTS
Determines the education, experience, and competencies that a person needs to have to do the job effectively
Preferred Education/ Qualification: B achelor's / Master's in Sciences/Pharmacy
Experience

• Preferably 15 + year s of experience in Quality Assurance /Quality Control / Manufacturing function of Sterile manufacturing facility

Core Competencies
Technical Skills:

• Knowledge of c urrent regulatory requirements (USFDA, India FDA , MHRA, EMEA)

• Thorough knowledge of cGMPs .

• Knowledge of various quality tools of investigations.

• Experience in explaining investigation in regulatory audits/inspection.

• Good comprehension of technical documentation.

• Ability to make technical and disposition decisions based on the outcome of investigations.

• E xperience in good understanding of quality systems.

Standards, Processes & Policies

• GMPs and regulations governing manufacturing and testing operations for sterile products.

• Global Pfizer quality system policies and procedures.

DESIRABLE REQUIREMENTS
Identify the 'nice to haves . These are not critical but would be advantageous .
Advanced Competencies

• Demonstrated ability to meet business targets and objectives

• Demonstrated ability to build rapport with relevant stake holders and facilitate service/project delivery across Process Streams.

• Experience and knowledge in the applications of Quality Systems.

• Demonstrated problem solving and negotiation skills.

• Excellent communication skills.

• Effective project management skills and demonstrated ability to manage multiple competing priorities.

• Able to provide customer focused flexible leadership.

• Highly organized and critical thinker.

• High Influencing skills and a bility to work with a team

Additional Desirable Requirements

• Trained and certified in Lean Six Sigma tools and tools used for investigation.

• Experience in handling of deviations through relevant tracking system

Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control