QC Compliance Specialist

Job Summary

Under limited supervision, manages laboratory compliance activities for assigned functions and projects. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Prepare and review the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOPs accordingly to company’s standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and update the related documents to implement the changes and ensure the compliance.

Area Of Responsibility

- Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOPs, compendial, ICH and FDA regulatory guidance.
- Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
- Evaluates compendial documents, and reviews procedures for laboratory compliance.
- Evaluate Sun global documents (GQS and GSOP) against site specific procedures and update the site procedure accordingly.
- Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.
- Generates change requests required for analytical documents, and routes documents for review and approval. Maintains hard copies and electronic file of technical documents.
- Timely provide the QC documents required for CBE, PAS and ANDA submission to RA.
- Collaborates with colleagues and external partners to achieve individual and department goals.
- Ensure compliance with cGMPs, DEA regulations and site operating procedures under the direction of QC Management.
- Ensure Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed on a timely fashion.
- Ensure continuous laboratory compliance by adopting best industry practice and complying with procedure requirements.

Work Conditions

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.
- Gases: Examples include carbon monoxide and ozone.
- Dust: Airborne particles of any kind, such as textile dust, wood, and silica.

Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.

Physical Requirements

- Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.
- Close vision; depth perception; ability to adjust focus
- Use of repetitive motion
- Able to operate computer/office machines
- Able to lift and carry up to 50 lbs.

Education and Job Qualification

- Minimum BS or equivalent degree in Chemistry or related discipline.
- Good computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
- Must have an understanding of FDA guidelines, ICH guidance and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management.
- Must have LIMS and SAP knowledge.
- Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
- Must have cGMP compliance knowledge and experience.
- Collaborates with colleagues and external partners to achieve primary Department goals.
- Works in coordination with project plans and goals as assigned by Management.
- Demonstrated strong communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- Excellent project management and problem solving skills.
- 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 four (3) years of experience in the pharmaceutical industry preferred.

Disclaimer

The preceding job description has been designed to indicate the general nature and level of work performed by employee 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 incumbent(s).

The presently-anticipated base compensation pay range for this position is $75,500 to $83,000. 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 Long Term Incentive Plan. 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.

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 Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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