Campus Pride Jobs

Job Title:

QC Team Lead Regulatory Compliance

Experience:

• Minimum of eight (8) years of experience in pharmaceutical analytical or Quality Control laboratory.

• Experience with generic pharmaceuticals with significant experience in solid dosage form testing.

• Strong experience in chromatography (HPLC and GC with Empower data acquisition software).

Summary:

This position reports to Section Head Quality Control, and this individual shall:

• Monitor Regulatory compliance related activities.. This includes pharmacopoeia monograph compliance, general chapters, FDA guidance related to quality control, gap assessments, etc.

• Provide troubleshooting support to the chemists in the QC Laboratory for new products and support to complete the activities timely, maximize their potential, and continuously improve their individual output to meet business needs.

• Support the laboratory management in performing investigations, laboratory incidences, and CAPA-related activities to meet cGMP compliance requirements.

• Supports execution of analytical method transfer activities for new projects.

• Prepares and reviews technical documents, including technical reports, gap assessments, change controls, etc.

• Provides technical expertise, and support to the laboratory staff.

• This is subject matter expert (SME) position with no direct reports.

Duties and Responsibilities:

• Help in standardizing work processes in the laboratory. Ensuring compliance to cGMP's and Standard Operating Procedures in the laboratory.

• Ensures that the analytical procedures established in the laboratory conform to current compendia and regulatory standards, and are suitable for use for their intended purpose.

• Develops and implements procedures, systems and training activities to develop an appropriate level of scientific expertise within the laboratory, to ensure the successful execution of project work to current pharmaceutical industry technical standards and to maintain compliance with cGMPs.

• Collaborates with colleagues in AR&D, RA, QC, QA, MSTG, and external partners and vendors or contractors to achieve project goals.

• Supports analytical method transfer activities for assigned projects.

Work Conditions:

• Environmental related to manufacturing/production/warehouse 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.

• Gases: Examples include carbon monoxide and ozone.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• 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 and stoop, kneel, crouch, crawl,push, and bend.

• Must be capable of bending and lifting, moving and/or carrying up to approximately 50 - 75pounds.

• Must be able to move pallets/equipment weighing about 100 -300 pounds using suitable moving equipment such as pallet jacks / Hi-Lo.

• Must have the ability to stand, ambulate and reach as required by job duties while navigating the office, lab, warehouse, and/or plant floor working environments.

• 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.

Qualifications/Education:

• Minimum BS in Chemistry or equivalent degree in related discipline; MS preferred.

• Strong and effective people management and interpersonal skills.

• The ability to organize complex work assignments and oversee analysts and staff to complete tasks and projects on time.

• Strong functional knowledge of cGMP compliance.

• Excellent working knowledge of USP, EP, ICH and FDA guidelines.

• Strong planning, written and oral communication skills.

• Excellent problem solving skills.

• A self-starter with a hands-on approach and a can-do attitude.

• 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).

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

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.