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QC Manager (Microbiology)

Pfizer


Location:
Kildare, OK 74604
Date:
12/05/2017
2017-12-052018-01-05
Pfizer
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Job Details

Closing date for applications: Friday 15th December 2017







QC Manager (Microbiology)



**JOB DESCRIPTION**



**JOB TITLE:** Quality Manager ( Microbiology Laboratory)







**SUPERVISOR'S TITLE:** Head of Quality Control Laboratories







**DEPARTMENT:** Quality







**JOB SUMMARY**



Management, oversight and technical control of all Quality Control Laboratory activities within the Microbiology Laboratory.







**II. JOB ACCOUNTABILITIES -** List the primary accountabilities and supporting activities in order of importance.



**Accountability**



Laboratory Control (Microbiology)



Administrating and exercising functional control of the Quality Control Laboratory such that a compliant, cost effective and efficient analytical service is provided.







Testing Program



Management of Laboratory testing aspect and assessment of data, assessment of all data produced for validation purposes, management and assessment of data generated for all other purposes. Management of microbiological testing of the Site Environmental Monitoring Program and Site Water Systems (Purified and Process Water).



Support of Site Investigations.







Personnel



Recruitment and retention of suitably qualified staff. Motivation, development, mentoring and training of those staff.







Compliance to cGMP



Assuring that all analytical testing performed within the Quality Control Laboratories is carried out in compliance with all site, Corporate and Regulatory policies, procedures and guidelines. Ensure adherence to cGMP and GLP.







Service to Process Teams



Provision of an efficient, customer focused service to the Process Teams.







**III. WORK FLOW** **Describe how the incumbent gets the work, the processes (mental/physical) which the incumbent performs to transform the work, the work output, and what happens to the work once the incumbent has finished.:**



**Inputs:**



Production plans



Direction from QC Lead



Site, Corporate and Regulatory Policies, Procedures and Guidelines



Resource management







**Output:**



Provision of high quality analytical testing data to support batch release, validation and GMP systems







**IV. DECISION MAKING** **A. Describe the decisions generally made and indicate whether the incumbent is the final authority or** **participates in the decisions:**







Release of laboratory analytical testing data (Final Authority)



Laboratory decision on investigations (Final Authority)



Business owner approval of SOPs, Testing Standards and Analytical Methods (Final Authority)



Laboratory approval of Validation Protocols (Final Authority)



Allocation of resources within areas of responsibility (Final Authority)







**Describe the effect the decisions can have on company programs, processes, services, customers or financial results:**







Cycle time



Compliance



Financial - Laboratory input to problem lot disposition







C. **Outline the guidelines, practices, or limits which are used in making decisions and which assist in recognizing the limits of authority.**



Adhere to all Site, Corporate and Regulatory Policies, Procedures and Guidelines



Escalate to next level of authority where concurrence is required







**V. SUPERVISION** **Describe the supervision this position receives. In what manner and how often are instructions given? How and with what frequency is the work checked?**







Level of supervision required is minimal. Reports to QC Lead.



Instructions given through weekly management meetings, 1-on-1 interactions, production schedule, validation master plans.







**VI. BUDGET/ASSET RESPONSIBILITY** **Describe the duties that relate to budget preparation.**







Needs understanding of capital and resource requirements within area of responsibility to assist in budget preparation.







**VI. INTERPERSONAL CONTACTS**







**Type**



**Reason for Contact**



**Frequency**



**A. Internal C** **ontacts**



Process Teams



QC Management Team



Support manufacturing production plans. Internal customer.



Daily/weekly







**QA**



Resolution of investigations. Audits. cGMP. Batch disposition. System owners of instruments



Daily/weekly







Technology



Participation in investigations. Protocol reviews. Analytical support to validation studies and process development.



Daily/weekly







EHS



Environmental Monitoring. Health and Safety. Maintaining regulatory requirements.



Weekly/Monthly







SS&L



Customer service. Vendor contracts. Service providers.



Weekly/Monthly







**B. External**



**To Pfizer**



Corporate



Corporate concurrence on critical investigation. Tech transfers.



Weekly/Monthly







Vendors



Provision of service and technical support to Laboratory apparatus, systems and equipment,



Weekly/Monthly







**VII. a CORE COMPETENCIES**



**Technical Competencies (Skills):**



**Description:**







**Demonstrates Business Acumen**



Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.







**Acts Decisively**



Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressures; able to make a quick decision.



Makes good decisions based upon a mixture of analysis, wisdom, experience and judgment; moist of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.







**Seizes Accountability**



Will stand up and be counted; doesn't shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment.



Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.







**Holds People Accountable**



Doesn't hold back anything that needs to be said; provides current, direct, complete and "actionable" feedback to others; lets people know where they stand; faces up to people problems on any person or situation quickly and directly; is not afraid to take negative action when necessary.



Clearly assigns responsibility for tasks and decisions, sets clear objectives and measures; monitors process, progress, and results; designs feedback loops into work.







**Builds Effextive Teams**



Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and successes; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of whole team; creates a feeling of belonging in the team.



Manages all kinds and classes of people equitably; deals effectively with all races, nationalities, cultures, disabilities, ages and both sexes; hires variety and diversity without regard to class; supports equal and fair treatment and opportunity for all.







**Grows Others**



Provides challenging and stretching tasks and assignments; holds frequent development discussions; is aware of each person's career goals; constructs compelling development plans and executes them; pushes people to accept developmental moves; will take on those who need help and further development; cooperates with the developmental system in the organization; is the a people builder.







**Self Awareness**



Picks up on the need to change personal, interpersonal and managerial behavior quickly; watches others for their reactions to his/her attempts to influence and perform, and adjusts; seeks feedback; is sensitive to changing personal demands and requirements and changes accordingly.







**Commits to "One Pfizer"**



Is aligned with the culture, values and mission; operates with the mission and values in mind; encourages others to act in a manner aligned with organizational culture, values and mission.



Communicates a compelling and inspired vision of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision shareable by everyone; can inspire and motivate entire units or organizations.







**Leads Change**



Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.



Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; provides individuals information so that they can make accurate decisions; is timely with information.



Is good at bringing the creative ideas of others to market; has good judgment about which creative ideas and suggestions will work; has a sense about managing the creative process of others; can facilitate effective brainstorming; can project how potential ideas may play out in the marketplace.







**VII.b EXPECTATIONS FOR THE DEMONSTRATION OF PFIZER VALUES**







**Customer Focus** - Start every meeting by asking who our customer is. Do we have a clear understanding of our customers needs? Are we focused on our objectives - or theirs?







**Community** - We play an active role in making the environment in which we operate a better place to live and work, knowing that it's ongoing vitality has a direct impact on the long term health of our business. We ask ourselves how we can use our talents and skills to help the business prosper and grow.







**Respect for People** - We recognize that people are the cornerstone of the Laboratory's success. We value our diversity as a source of strength and are proud of our history of treating colleagues with dignity and respect. We strive to embrace and understand different styles and viewpoints, and are open and to be open and constructive with each other.







**Performance** - We strive for continuous improvement in our performance, measuring results carefully and ensuring that integrity and respect for people are never compromised. We strive to make continuous improvement a way of life every day, pursue activities that add the greatest value and hold ourselves accountable, learning from our mistakes.







**Collaboration** - To be a successful company we must work together as a unit, frequently transcending organizational boundaries to meet the changing needs of our customers. We strive to involve the right people at the right time, and stand together to execute a decision.







**Leadership** - We believe that Leaders empower those around them by sharing knowledge and rewarding outstanding individual effort. We are dedicated to providing Leadership opportunities at all levels in the laboratory organization. We ask all colleagues to challenge the status quo, drive performance and model the behaviors that we want to see.







**Integrity** - We demand of ourselves and others the highest ethical standards, and our data and processes will be of the highest quality. We strive to do the right thing in the right way and are proud to explain how we achieve results.







**Quality** - Quality is ingrained in the work of our colleagues and all our values. Our business practices and process are designed to achieve quality results that exceed the expectations of all our stakeholders.







**Innovation** - Challenge our processes. Is there a better way? Look beyond the obvious. Be curious. Don't stop when you meet and obstacle, persevere and think of ways to overcome it. Be creative and share your ideas.







**VIII. TRAINING AND EXPERIENCE**







**1. What formal education is required to perform job duties. (Degree, field ?)**







University or College Degree from a recognised institution in a Science discipline







**2. What training is required ?**







As per Training Curriculum and Management Development program.







**3. List specific skills and minimum expertise (e.g. computer skills) required to perform job duties.**







Min. 5 years Pharmaceutical QC experience, including several years at Supervisory level.



Good organisational and time management skills.



Knowledge of regulatory requirements



Good communication and interpersonal skills. Ability to lead a technical team.







IX. **JOB IMPACT** **Describe the effect the job duties have on the organizational unit, the company and/or other employees.**



Efficient delivery of a high quality analytical service. Maintaining Lab Compliance to all Site, Corporate and Regulatory Policies, Procedures and Guidelines. Leading by example.







X. **SUPERVISION**



**Total Number Supervised: 10+**



Chemists/ Microbiologists



Senior Chemists/ Microbiologists



Specialists



Senior Specialists







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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