Associate, Contract Manufacturing Quality

Contract Manufacturing Associate

Job Summary
Support Quality activities at Contract Manufacturing Organizations (CMO) by providing timely and effective quality oversight. Accomplish quality objectives by planning and evaluating project activities. Support may include operations and validation.

Area of Responsibility

Review of manufacturing and packaging records
Review certificate of analysis and Certificate of compliance
Ensure the release packages are ready prior to batch disposition
Review of QMS records submitted by CMO and monitoring (e.g. change controls/deviations, quality agreements but not limited to)
Manage and oversee complaint, change control, and variation-filing modules for CMO activity.
Actively participate in day to day meetings
Participate in the qualification process and support assigned CMO aligned with the Sun Pharma Quality Management Systems and provide reports as required.
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine CMO business review.
Implement and maintain Regional CMO data in the Global CMO database.
Ensure the Quality Assurance Agreements which are created and maintained according to Sun Pharma requirements, are regularly reviewed and followed.
Conduct review and approve batch release documentation.
Support significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
Maintain annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.
Manage and oversee complaint module for Ohm Site. Work Conditions:

Office Environment
Lab Environment
Manufacturing Environment
Environmental related to manufacturing/production environments:
Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
Odors: Unpleasant smells.

JOB DESCRIPTION
Gases: Examples include carbon monoxide and ozone.
Dust: Airborne particles of any kind, such as textile dust, wood, and silica. Physical Requirements:
While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
Must be capable of bending and lifting, moving and/or carrying up to approximately 20 pounds.
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes. Travel Estimate
Up to 10 % Education and Job Qualification
Minimum of a Bachelor’s degree in a scientific discipline; MS preferred.
Certified Quality Auditor (e.g. ASQ) certification preferred.
Expert skills related to investigations (e.g. Lean Six Sigma) Quality Agreements, and CMO management.
Ability to identify key priorities necessary for and be able to author/implement global policies and procedures.
Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals/tools.
Strong knowledge of cGMP, QA/QC and regulatory compliance (US, EU and other regulatory requirements).
Strong interpersonal and communication, both written and verbal, skills.
Good negotiation and influencing skills.
Operational knowledge of pharmaceutical processing and packaging operations.
Task oriented team plan who is able to manage multiple complex priorities and work in a cross-cultural working environment.
The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). Experience

Minimum of five (05) years of related experience in a cGMP environment, preferably in a project management capacity for pharmaceutical or biotechnology industries.

Experience in drug product sterile pharmaceutical/biologics manufacturing and QC is an asset.

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

EEO Notice:

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral