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QA Specialist (Validation)


Tuas South Ave 6
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Job Details

We are looking for an enthusiastic and motivated individual, who has experience in managing process qualification and validation lifecycle in pharmaceutical operations; with experience in API operations being well regarded; and who is looking to join a dynamic team. The incumbent will be responsible for the creation and review of qualification and validation documentation and ensure it complies with global regulatory requirements and the Pfizer Quality Standards (PQS). The incumbent will also be accountable for providing quality oversight in key quality systems (i.e. change control, deviation investigation, CAPA, etc) relating to manufacturing process systems, facility, equipment, cleaning and solvent recovery qualification and validation activities.


The incumbent will coordinate and support the QA compliance for Validation processes and qualification activities at the site. This will involve the validation activities for manufacturing processes, cleaning processes, GMP computer systems, laboratory equipment, plant equipment, plant facilities and site utilities. In conjunction with process validation activities the incumbent will work with equipment, utilities, instrument and raw material and packaging vendors to ensure they are adequately qualified in accordance with the requirements outlined in the approved Validation Master Strategy to support the API manufacturing processes on site in full compliance with predicate rules and Pfizer internal validation requirements.

The core competencies required for this position will be a working knowledge of validation principles in accordance with the current codes of Good Manufacturing Practices (cGMPs) and Good Automated Manufacturing Practices (GAMP), vendor management experience, change management skills, report writing skills, and the ability to manage projects and meet deadlines. The incumbent will interact with all departments on site and will need to have good interpersonal skills.



+ Lead local validation activities (e.g. process, cleaning, computer systems, laboratory equipment, plant equipment, facilities, utilities and process analytical technology) and support global data integrity systems initiatives.

+ Prepare and review qualification documentation.

+ Support process changes and assess validation impact of deviations.

+ Maintain validation status of plant, review changes and carry out periodic reviews.

+ Ensure compliance to regulatory standards and commitments/ lead internal and external Good Manufacturing Practice (GMP) audits.

+ Maintain GMP policies, procedures and site metrics.

Job Relate Requirements:

+ Thorough knowledge of GMP, validation regulations, ICH Q7a Guidelines, Good Documentation Practices (GDP), Good Automation Manufacturing Practice (GAMP) and other applicable regulations.

+ Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.

+ Previous Quality Assurance and/or Validation management experience.

+ Demonstrated ability to interact effectively with management, auditors and regulators.

+ Ability to interact effectively in teams and facilitate team discussions.


+ Ensure validation activities are carried out as per approved procedures and policies.

+ Conduct internal audit to ensure compliance to Pfizer Quality Systems (PQS).

+ Reviewing and approving change controls and deviation investigations.

+ Reviewing and approving GMP documents.


The incumbent will interact with all site departments i.e. Procurement Manufacturing Operations, Quality Control, Quality Assurance, Warehouse and Tank Farm teams and Engineering teams for GMP related validation management activities.


A Bachelor Degree in Science / Engineering / Computer Science or equivalent with relevant pharmaceutical experience. Familiar with self-directed team concept; manufacturing operations applications; six sigma and lean principles and process improvement tools.


Minimum 5-8 years' experience in pharmaceutical GMP-regulated industries (Biotech preferred) and minimum 5 years' thereof in Quality Assurance and/or Validation experience within the pharmaceutical industry. A minimum of 3 years' experience in Quality Assurance role within the pharmaceutical industry.

Flexi Work - Tuas (Singapore)

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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