JOB DESCRIPTION
DATE: / January 2018
POSITION: / Analytical/Senior Analytical Chemist (Quality Control)
BUSINESS UNIT: / Sciences
LOCATION: / Craigavon
REPORTING TO: / Team Leader/Principal Analyst/ Technical Leader
RESPONSIBLE FOR (PEOPLE): / N/A

OVERALL ROLE OBJECTIVE:

To perform, monitor and accept accountability for all assigned analytical duties relating to the QC operations within Almac Sciences GMP Manufacturing facilities. To perform analysis as required, assisting in the efficient operation of the laboratory and to ensure that schedules are met and that the quality of work meets specified standards.

JOB SPECIFIC RESPONSIBILITIES:

The post holder will:

1.  Provide GMP analytical support to the GMP Manufacturing facilities, including

·  Testing of raw materials

·  Analysis of in-process control samples

·  Analysis of isolated intermediates

·  Analysis of final API samples

·  Analysis of cleaning samples

·  Swabbing of Manufacturing equipment

·  Performing Environmental Monitoring

·  Analysis of samples from the Purified Water plant

2.  Be trained and be fully competent in the following analytical techniques:

·  HPLC

·  GC

·  NMR

·  IR

·  UV

·  MS

·  KF

·  Classical techniques

·  PSA

·  IC

3.  Perform analytical duties right-first-time in order to complete work within the budgeted resource time and in line with agreed timelines.

4.  Prepare and review data and documents accurately and efficiently, in-line with the Quality Unit’s culture of Right-First-Time.

5.  Retain an up to date knowledge of analytical techniques and equipment.

6.  Be responsible for the management of own work schedule and provide regular updates to line manager and team members.

7.  Ensure that unplanned deviations (UPDs) are kept to a minimum and that your line manager is notified as soon as UPDs are generated.

8.  Ensure that any corrective or preventative action arising from UPDs is completed in full and within allocated timeframes.

9.  Assist with the identification of alternative test methods and/or equipment to improve efficiency and maximise throughput of testing in the laboratories.

10.  Make suggestions for the improvement of efficiency and/or reduction in operating costs within the QC Department and the wider company.

11.  Identify incidents of out of specification results and inform the Line Manager

12.  Assist in the generation of specifications and SOPs relevant to the Analytical/ QC Laboratories, ensuring that current versions are available.

13.  Inform supervisor on a regular basis of progress and any circumstances that alter agreed timescales.

14.  Ensure that laboratory equipment remains in calibration and functions as required. Where this is not the case refer to the appropriate persons for action.

15.  Ensure that lab and write-up areas are maintained in an audit-ready condition at all times.

16.  Perform other duties as may be deemed appropriate by the Line Manager and that fall within the general remit of the post.

GENERAL ROLE RESPONSIBILITIES:

Quality / Ensure GMP is adhered to in all areas of work.

Health & Safety

/ Understand Company’s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place.

Training and Development

/ Ensure training has been received before undertaking specific duties and that all training is recorded in training records.

Human Resource Management

/ Adhere to all HR policies and procedures, to include all absence policies and procedures.

Communication

/ Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects.

Equal Opportunities

/ Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur.

Core Competency Framework

/ Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework.
By signing this Job Description I accept that I have received and read the Job Description and have accepted the responsibilities identified therein.
EMPLOYEE’S SIGNATURE:
PRINT NAME:
DATE:
This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual jobholder works. It is not intended to be rigid or inflexible and may alter as the Company’s strategic direction changes.

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PERSON SPECIFICATION
DATE: / January 2018
POSITION: / Analytical/Senior Analytical Chemist
BUSINESS UNIT: / Sciences
LOCATION: / Craigavon
REPORTING TO: / Team Leader/Principal Analyst/ Technical Leader
RESPONSIBLE FOR (PEOPLE): / N/A
/ ESSENTIAL
REQUIREMENT /

DESIRABLE

REQUIREMENT

/ ASSESSMENT METHOD
QUALIFICATIONS / Degree level qualification (or equivalent) in a Life Science related discipline / Degree level qualification (or equivalent) in an Analytical related discipline / Application Form and Documentary Evidence
EXPERIENCE / Previous analytical experience within industry (i.e. pharmaceuticals/fine chemistry)
Working knowledge of multiple analytical techniques (HPLC, GC, IR, NMR, MS, KF)
Experience of drug substance or drug product analysis in a GMP environment / Experience in method development and/or validation
Working knowledge of COSHH
Previous experience in a supervisory role / Application Form and Interview
KEY SKILLS / Basic level ability in the use of Microsoft Packages (Word, Excel etc)
Excellent communication skills (verbal and written)
Proven ability to apply a meticulous approach to tasks undertaken
Proven ability to organise and plan work both independently and in conjunction with team members / Proficiency in the use of Microsoft Packages (Word, Excel etc) / Interview
ALMAC CORE COMPETENCIES
COMPETENCY / BEHAVIOUR /

ASSESSMENT METHOD

RESULTS DELIVERY / Delivers results on time, within constraints and in line with company policy and procedure and organisational strategy. Demonstrates a continuous drive for quality and a commitment to excellence. / Interview
PROACTIVE SOLUTIONS / Analyses and uses experience and logical methods to make sound decisions which solve difficult problems. Seeks practical/workable and innovative methods to deliver solutions. / Interview
LEADS BY EXAMPLE / Promotes a clear vision and mission. Acts as a positive role model for the organisation, fostering a climate of teamwork and development. / Interview
COMMUNICATION / Communicates clearly and effectively. Promotes the exchange of ideas and information across the organisation. Fosters dialogue to ensure everyone understands what is going on. / Interview
CUSTOMER FOCUS / Strives to exceed the expectations and requirements of internal and external customer; acts with customers in mind and values the importance of providing high-quality customer service. / Interview
JOB SPECIFIC KNOWLEDGE / Demonstrates required job knowledge and understanding to successfully and competently fulfill or exceed the requirements of their post. Follows correct procedures and guidelines (SOPs).
Proactively demonstrates a desire to enhance and develop their job knowledge. / Interview

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